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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture Removal Kit
510(k) Number K915827
Device Name A.C.S. SUTURE REMOVAL KIT
Applicant
American Carolina Stamping
P.O. Box 1079
Etowah,  NC  28729
Applicant Contact STEVE MCNABB
Correspondent
American Carolina Stamping
P.O. Box 1079
Etowah,  NC  28729
Correspondent Contact STEVE MCNABB
Regulation Number878.4800
Classification Product Code
MCZ  
Date Received12/30/1991
Decision Date 12/08/1992
Decision Substantially Equivalent - Kit (SESK)
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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