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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 K982941
FOIA Releasable 510(k) K982941
Device Name HEM-O-LOK MODEL NUMBERS 523900, 523970
Applicant
Weck Closure Systems
1 Weck Dr.
Research Triangle Park,  NC  27709
Applicant Contact JAMES L LUCKY
Correspondent
Weck Closure Systems
1 Weck Dr.
Research Triangle Park,  NC  27709
Correspondent Contact JAMES L LUCKY
Regulation Number878.4300
Classification Product Code
FZP  
Date Received08/21/1998
Decision Date 11/19/1998
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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