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510(k) K912053

Device
OPEN HEART TRAY
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
510(k) number
K912053
Product code
FSM  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-26
Date received
1991-05-09
Regulation
878.4800
Classification name
Tray, Surgical, Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALAN P.SCHWARTZ
Address
55 Northern Blvd., Suite 301 Great Neck NY US 11021 11021

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
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
K883125CASF STERILIZATION TRAYTerray Manufacturing, Inc.1988-08-10

Legacy Summary#

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FDA Review#

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