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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 K021808
FOIA Releasable 510(k) K021808
Device Name WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
Applicant
Weck
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact JAMES LUCKY
Correspondent
Weck
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact JAMES LUCKY
Regulation Number878.4300
Classification Product Code
FZP  
Date Received06/03/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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