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510(k) K892389

Device
BIOPSY KIT
Applicant
I M, INC.
510(k) number
K892389
Product code
LRO  
Decision
Substantially Equivalent - With Drug (SESD)
Decision date
1989-07-17
Date received
1989-04-07
Regulation
878.4370
Classification name
General Surgery Tray
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
AMIR PORAT
Address
P.O. Box 658 Fairfield NJ US 07004 07004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213481Medline General Surgery TrayMedline Industries, Inc.2022-05-24
K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.2021-12-03
K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.2004-11-30
K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical Products2003-03-31
K023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.2002-12-09
K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC1998-01-30
K971061OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAYOpportunity, Inc.1997-06-11
K971062OPPORTUNITY INC. GENERAL PURPOSE TRAYOpportunity, Inc.1997-06-09
K932221NEUROLOGICAL OR CRANI TRAYS (PACKS)Associated Medical Products Co.1997-03-19
K970286PRESBYTERIAN LINEN SERVICES SURGICAL PACKSMedline Industries, Inc.1997-03-10
K970187RUNYON LARGE VOLUME PARACENTESIS KITGi Supply1997-02-14
K965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1997-02-14
K964921BASIC BIOPSY TRAY. DISPOSABLE, STERILETrinity Laboratories, Inc.1997-01-22
K963721SKIN SCRUB TRAYGrand Medical Products1996-11-27
K963715DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAYGrand Medical Products1996-11-27

Legacy Summary#

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FDA Review#

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