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510(k) K820344

Device
ROWE SHOULDER INSTR. FOR BANKHART REPAIR
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
510(k) number
K820344
Product code
HTD  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-08
Date received
1982-02-08
Regulation
878.4800
Classification name
Forceps
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051281THE NEEDLE CATCHERE.D.Medical , Ltd.2005-09-08
K974593SEMKIN INSULATED BIPOLAR FORCEPTitan Mfg., Inc.1998-06-24
K974594SEMKIN BIPOLAR FORCEPTitan Mfg., Inc.1998-06-24
K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPTitan Mfg., Inc.1998-06-24
K913964MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPSMarlo Surgical Technology1991-10-23
K911180CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPSNorthgate Technologies, Inc.1991-03-29
K895212TIK EXTRAKTORInstruments of Sweden, Inc.1989-09-27
K890369GALL STONE FORCEPSKinetic Medical Products1989-02-03
K890373HEMORRHOIDAL FORCEPSKinetic Medical Products1989-02-03
K890213MICROSURGICAL FORCEPSKinetic Medical Products1989-01-27
K890226SURGICAL FORCEPSKinetic Medical Products1989-01-27
K890234SUTURE CLIP REMOVERKinetic Medical Products1989-01-27
K890238CATHETER FORCEPSKinetic Medical Products1989-01-27
K890244TUBING CLAMP FORCEPSKinetic Medical Products1989-01-27
K890246ARTERY FORCEPSKinetic Medical Products1989-01-27

Legacy Summary#

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FDA Review#

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