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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 K880785
Device Name SKILCRAFT
Applicant
Pennsylvania Association For the Blind
Washington-Green County Branch
566 E. Maiden St.
Washington,  PA  15301
Applicant Contact PILGUN, II
Correspondent
Pennsylvania Association For the Blind
Washington-Green County Branch
566 E. Maiden St.
Washington,  PA  15301
Correspondent Contact PILGUN, II
Regulation Number878.4800
Classification Product Code
KDD  
Date Received02/26/1988
Decision Date 03/11/1988
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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