Accutome Inc

FDA Filings

This page includes the latest FDA filings for Accutome Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Accutome Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Claudia Hill

FDA Registration(s)

• Registration Number: 2521877
• FEI Number: 2521877
• Name: ACCUTOME, INC.
• Owner & Operator: ACCUTOME, INC.
• Contact Address: 3222 Phoenixville Pike --; Malvern PA 19355 US
• Official Correspondent:
  • Claudia Hill
  • x-610-8890200-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3222 Phoenixville Pike ; Malvern, PA 19355 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00897826002253 ACCUTOME, INC.	Pachpen- VET 24-5100-V	2021-11-29
GUDID 00897826002239 ACCUTOME, INC.	B-scan Pro- VET 24-6400-V	2021-11-29
GUDID 00897826002222 ACCUTOME, INC.	B-scan Plus- VET 24-6100-V	2021-11-29
GUDID 00897826002208 ACCUTOME, INC.	B-scan Pro Software Package: Veterinary Version	2021-11-29
GUDID 00897826002192 ACCUTOME, INC.	B-scan Plus Software Package: Veterinary Version	2021-11-29
GUDID 00897826002185 ACCUTOME, INC.	A-scan Plus Connect: Software Package	2021-11-29
GUDID 00897826002178 ACCUTOME, INC.	B-scan Plus: Software Package	2021-11-29
GUDID 00897826002147 ACCUTOME, INC.	4Sight: Software Package	2021-11-29
GUDID 00897826002116 ACCUTOME, INC.	AccuTip Cover AX11286	2021-11-29
GUDID 00897826002109 ACCUTOME, INC.	AccuTip Cover AX11526	2021-11-29
GUDID 00897826002093 ACCUTOME, INC.	AccuTip Cover AX11932	2021-11-29
GUDID 00897826002086 ACCUTOME, INC.	AccuTip Cover AX9950	2021-11-29
GUDID 00897826002079 ACCUTOME, INC.	4Sight 24-8000	2021-11-29
GUDID 00897826002062 ACCUTOME, INC.	B-scan Pro 24-6400	2021-11-29
GUDID 00897826002055 ACCUTOME, INC.	Accupach VI 24-6200	2021-11-29
GUDID 00897826002031 ACCUTOME, INC.	B-scan Plus 24-6100	2021-11-29
GUDID 00897826002024 ACCUTOME, INC.	A-scan Plus Connect 24-4400	2021-11-29
GUDID 00897826002017 ACCUTOME, INC.	Pachpen 24-5100	2021-11-29
GUDID 00897826002000 ACCUTOME, INC.	Accupen 24-3000	2021-11-29
PMN K152573 | IYO ACCUTOME, INC.	4Sight	2015-11-30
PMN K152573 | ITX ACCUTOME, INC.	4Sight	2015-11-30
PMN K152573 ACCUTOME, INC.	4Sight	2015-11-25
PMN K132549 | HKY ACCUTOME, INC.	AccuTip Cover	2014-04-25
PMN K132549 ACCUTOME, INC.	ACCUTIP COVER	2014-04-23
PMN K123349 | IYO ACCUTOME, INC.	A-Scan Plus Connect	2013-02-08
PMN K123349 | ITX ACCUTOME, INC.	A-Scan Plus Connect	2013-02-08
PMN K123349 ACCUTOME, INC.	A-SCAN PLUS CONNECT	2013-01-29
PMN K103471 | IYN ACCUTOME, INC.	UBM Plus	2012-12-18
PMN K103471 | ITX ACCUTOME, INC.	UBM Plus	2012-12-18
OJK ACCUTOME, INC.	PDT Kit	2011-04-22
PMN K960765 | IYO ACCUTOME, INC.	Advent A/B	2011-04-08
PMN K960765 | ITX ACCUTOME, INC.	Advent A/B	2011-04-08
PMN K103471 ACCUTOME, INC.	UBM PLUS	2011-03-14
PMN K100500 | HJO ACCUTOME, INC.	PSL Classic Slit Lamp	2010-08-09
PMN K083377 | HKX ACCUTOME, INC.	AccuPen	2010-02-02
GZX ACCUTOME, INC.	Nerve Cutting Knife, AK7000	2010-02-02
HJW ACCUTOME, INC.	Roland Darkadoptometer	2009-05-11
HOX ACCUTOME, INC.	Stimuli CVT	2009-02-25
HNJ ACCUTOME, INC.	Punch, Kelly	2009-01-22
PMN K070943 | IYO ACCUTOME, INC.	B-Scan Plus	2008-12-16
PMN K070943 | ITX ACCUTOME, INC.	B-Scan Plus	2008-12-16
PMN K050552 | IYO ACCUTOME, INC.	PachPen Pachymeter	2008-12-16
PMN K042752 | IYO ACCUTOME, INC.	Pach V Pachymeter	2008-12-16
PMN K032956 | IYO ACCUTOME, INC.	A-Scan Plus	2008-12-16
PMN K023525 | GWE ACCUTOME, INC.	Reti-port / Reti-Scan 21	2008-12-05
PMN K053638 | GAP ACCUTOME, INC.	SUTURE PACK (SILK)	2007-02-08
PMN K053638 | GAP ACCUTOME, INC.	MANI NEEDLE	2007-02-08
PMN K053637 | GAR ACCUTOME, INC.	SUTURE PACK (NYLON)	2007-02-08
PMN K053637 | GAR ACCUTOME, INC.	MANI NEEDLE	2007-02-08
PMN K053636 | GAM ACCUTOME, INC.	SUTURE PACK (PGA SBSORBABLE)	2007-02-08
PMN K053636 | GAM ACCUTOME, INC.	MANI NEEDLE	2007-02-08
PMN K050150 | GDL ACCUTOME, INC.	SUTURE PACK (POLYESTER)	2007-02-08
PMN K050150 | GDL ACCUTOME, INC.	MANI NEEDLE	2007-02-08
PMN K050150 | GAT ACCUTOME, INC.	SUTURE PACK (POLYESTER)	2007-02-08
PMN K050150 | GAT ACCUTOME, INC.	MANI NEEDLE	2007-02-08
HQT ACCUTOME, INC.	IMMERSION SHELL	2005-06-02
PMN K050552 ACCUTOME, INC.	PACHPEN PACHYMETER, MODEL 24-5100	2005-03-28
PMN K032956 ACCUTOME, INC.	ACCUSONIC A-SCAN MODEL, 24-4000	2003-10-10
HMR ACCUTOME, INC.	OPHTHALMIC MARKER	2000-06-01
HMR ACCUTOME, INC.	OCULAR	2000-06-01
HNN ACCUTOME, INC.	DIAMOND OPHTHLMIC KNIFE	2000-04-24
HNN ACCUTOME, INC.	ACCUSHARP OPHTHALMIC KNIFE	2000-04-24
HNH ACCUTOME, INC.	OPHTHALMIC RING	2000-04-24
HNZ ACCUTOME, INC.	OPHTHAMIC CURETTE	2000-03-30
FHQ ACCUTOME, INC.	ACCUTOME	1999-02-18
HXB ACCUTOME, INC.	ACCUTOME	1999-02-16
HRM ACCUTOME, INC.	ACCUTOME	1999-02-16
HON ACCUTOME, INC.	ACCUTOME	1999-02-16
HOE ACCUTOME, INC.	ACCUTOME	1999-02-16
HNX ACCUTOME, INC.	ACCUTOME	1999-02-16
HNW ACCUTOME, INC.	ACCUTOME DILATORS	1999-02-16
HNR ACCUTOME, INC.	ACCUTOME	1999-02-16
HNQ ACCUTOME, INC.	ACCUTOME	1999-02-16
HNF ACCUTOME, INC.	ACCUTOME	1999-02-16
HND ACCUTOME, INC.	ACCUTOME	1999-02-16
HNC ACCUTOME, INC.	ACCUTOME	1999-02-16
HNB ACCUTOME, INC.	ACCUTOME	1999-02-16
HMX ACCUTOME, INC.	ACCUTOME	1999-02-16
JYJ ACCUTOME, INC.	KREMER BLOCK GAUGE	1992-07-29
JYJ ACCUTOME, INC.	KREMER BLADE GAUGE	1992-07-29
FSM ACCUTOME, INC.	GENERIC	1992-07-29
EMF ACCUTOME, INC.	AccuSharp Ophthalmic Knife	1992-07-29
EMF ACCUTOME, INC.	ACCUTOME SURGICAL KNIFE	1992-07-29
PMN K820050 ACCUTOME, INC.	KREMER BLADE GAUGE	1982-02-24
PMN K810660 ACCUTOME, INC.	KREMER CORNEOMETER ULTRASONIC PACHOMETER	1981-08-21

Similar & Related FDA Registered Companies

• ACCUTOME ULTRASOUND, INC.

Related Finance Registrations

NCAGE Code	1PQJ9	ACCUTOME, INC.
CAGE Code	1PQJ9	ACCUTOME, INC.
S.A.M. Registration	1PQJ9 [48792816]	ACCUTOME, INC.
DUNS	048792816	Accutome, Inc.