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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 K003337
FOIA Releasable 510(k) K003337
Device Name HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
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 Received10/25/2000
Decision Date 12/21/2000
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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