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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K853910
Device Name SUTURE REMOVAL KIT
Applicant
Scientific & Medical Care Co.
P.O. Box 40284
Washington,  DC  20016
Applicant Contact BAYO OSHINNAIYE
Correspondent
Scientific & Medical Care Co.
P.O. Box 40284
Washington,  DC  20016
Correspondent Contact BAYO OSHINNAIYE
Regulation Number878.4800
Classification Product Code
KDD  
Date Received09/20/1985
Decision Date 10/08/1985
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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