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510(k) K772286

Device
FORCEPS, SUTURE, AUTO
Applicant
HARTMANN GROUP, INC.
510(k) number
K772286
Product code
GDO  
Decision
Substantially Equivalent (SESE)
Decision date
1977-12-20
Date received
1977-12-12
Regulation
878.4800
Classification name
Applier, Surgical, Clip
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K926199UNICLIP SURGICAL CLIP APPLIERUnisurge, Inc.1993-04-20
K890941MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APPUnited States Surgical, A Division of Tyco Healthc1989-04-07
K890159TOWEL CLIPSDhason Brothers, Inc.1989-02-03
K890233SUTURE CLIP APPLIER/REMOVERKinetic Medical Products1989-01-27
K820837DISPOSABLE MULTIPLE LIGATING CLIPETHICON, Inc.1982-05-28
K812291ETHICON MULTIPLE LIGATING CLIP APPLIERETHICON, Inc.1981-09-11
K792378HEMOSPENSER CARTRIDGE CAT. NO. 523500-Edward Weck, Inc.1979-12-06
K791845BAYONET HEIFETZ CLIP APPLIERSEdward Weck, Inc.1979-10-17
K790855SURGICAL DRAPE CLIP #201C. Intl.1979-08-03
K791157360 HEMOCLIP APPLIERSEdward Weck, Inc.1979-06-27
K790990REYNOLDS DOUBLE HEMOCLIP APPLIERSEdward Weck, Inc.1979-06-05
K771412LIGACLIP MULTIPLE CLIP APPLIERETHICON, Inc.1977-11-28
K771640SUTURE CLIP REMOVERUnited States Surgical, A Division of Tyco Healthc1977-09-30

Legacy Summary#

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FDA Review#

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