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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 K944552
Device Name PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP
Applicant
PILLING WECK, INC.
1 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact PONZELLE ROYSTER
Correspondent
PILLING WECK, INC.
1 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact PONZELLE ROYSTER
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/16/1994
Decision Date 11/07/1994
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
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