FDA.reportPublic FDA data

510(k) K843723

Device
STERILE INSTRUMENT TRAYS-VARIOUS
Applicant
E.M. ADAMS
510(k) number
K843723
Product code
FSM  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-23
Date received
1984-09-24
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
RICHARD K DONAHUE
Address
121 W. St. Medfield MA US 02052 02052

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases