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510(k) K863091

Device
BICORD BY QMED
Applicant
QMED, INC.
510(k) number
K863091
Product code
HAM  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-29
Date received
1986-08-13
Regulation
878.4400
Classification name
Apparatus, Electrosurgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LARRY D POTTS
Address
3001 W. Kentucky St. Louisville KY US 40211 40211

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd.2016-06-23
K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc.2000-02-04
K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)Paladin Medical, Inc.1999-11-03
K945861BERGEN 710 ESUBergen Mfg.1995-03-01
K913300LAPAROSTAT(TM)Cook Ob/Gyn1992-04-02
K920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.1992-02-03
K911353EMC MODEL NO. STATOME 900Emc Industries1991-06-24
K901248ABC HANDPIECE ADAPTERBeacon Laboratories, Inc.1990-04-03
K881334LIGHT COAGULATOR LC 250Nk-Optik GmbH1989-11-16
K895337ELECTROSURGICAL COAGULATION SUCTION TUBENew England Surgical Instrument Corp.1989-09-15
K894663BEAMER ONEBeacon Laboratories, Inc.1989-09-15
K894762B100 DISPOSABLE HANDPIECEBeacon Laboratories, Inc.1989-09-15
K884171#875 DISPOSABLE BIOPOLAR CABLEOlsen Electrosurgical, Inc.1988-10-24
K884172MODIFIED OLSEN #770 DISPOSABLE HOLSTEROlsen Electrosurgical, Inc.1988-10-24
K884173#920 DISPOSABLE TUR CABLEOlsen Electrosurgical, Inc.1988-10-24

Legacy Summary#

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FDA Review#

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