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510(k) K854746

Device
SURGICAL INSTRUMENT TRAY
Applicant
ZBI, INC.
510(k) number
K854746
Product code
FSM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-17
Date received
1985-11-26
Regulation
878.4800
Classification name
Tray, Surgical, Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATTHEW H BROWN
Address
1138 W. Chester Pike, Suite 7 West Chester PA US 19382 19382

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FSM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.1997-05-06
K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.1996-08-09
K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.1994-11-22
K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.1991-08-29
K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.1991-08-26
K912052HEART CATH TRAYMedical Device Inspection Co., Inc.1991-08-20
K912104MAJOR BASIN TRAYMedical Device Inspection Co., Inc.1991-08-09
K910570SPLINTER TWEEZERSSolan Scissors Sales1991-05-31
K911601REDDICK TROCAR AND CANNULAIdeal Medical, Inc.1991-05-21
K910328KEY COMFORT GRIPSKey Surgical, Inc.1991-03-06
K905682RICHARD-ALLAN CLAMP COVERSRichard-Allan Medical1991-02-19
K900376HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)Pmt Corp.1990-04-10
K894610CUSTOM TRAYS, KITSL H M Ent., Inc.1990-03-15
K900479STERILE LACERATION TRAY CAT. #749Busse Hospital Disposables, Inc.1990-02-13
K895527THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEMQuantitative Technologies, Inc.1989-10-06

Legacy Summary#

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FDA Review#

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