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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K953908
Device Name DAVIS & GECK LIGATING CLIP REMOVER
Applicant
DAVIS & GECK, INC.
ONE CASPER ST.
DANBURY,  CT  06810
Applicant Contact STEPHEN J TAMSETT
Correspondent
DAVIS & GECK, INC.
ONE CASPER ST.
DANBURY,  CT  06810
Correspondent Contact STEPHEN J TAMSETT
Regulation Number878.4300
Classification Product Code
FZP  
Date Received08/21/1995
Decision Date 11/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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