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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 K851251
Device Name AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200
Applicant
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Applicant Contact GLENN M MATTEI
Correspondent
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Correspondent Contact GLENN M MATTEI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/27/1985
Decision Date 07/02/1985
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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