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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 K982313
Device Name HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
Applicant
Weck Closure Systems
1 Weck Dr.
Research Triangle Park,  NC  27709
Applicant Contact BRIAN YOUNG
Correspondent
Weck Closure Systems
1 Weck Dr.
Research Triangle Park,  NC  27709
Correspondent Contact BRIAN YOUNG
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/01/1998
Decision Date 08/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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