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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Removable (Skin)
510(k) Number K943719
Device Name VISISTAT STAPLER
Applicant
Pilling Weck, Inc.
1 Weck Dr.
Research Triangle Park,  NC  27709
Applicant Contact PONZELL ROYSTER
Correspondent
Pilling Weck, Inc.
1 Weck Dr.
Research Triangle Park,  NC  27709
Correspondent Contact PONZELL ROYSTER
Regulation Number878.4760
Classification Product Code
GDT  
Date Received08/01/1994
Decision Date 08/24/1994
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
Predetermined Change
Control Plan Authorized		 No
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