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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 K993157
FOIA Releasable 510(k) K993157
Device Name HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
Applicant
Weck Closure Systems
One Weck Dr.
Research Triangle Park,  NC  27709
Applicant Contact BRIAN YOUNG
Correspondent
Weck Closure Systems
One Weck Dr.
Research Triangle Park,  NC  27709
Correspondent Contact BRIAN YOUNG
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/21/1999
Decision Date 12/17/1999
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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