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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K863885
Device Name SABLE BLADES
Applicant
Sable Industries
College Plz., P.O. Box 6242
Oceanside,  CA  92056
Applicant Contact DIMITRI G MONDIADIS
Correspondent
Sable Industries
College Plz., P.O. Box 6242
Oceanside,  CA  92056
Correspondent Contact DIMITRI G MONDIADIS
Regulation Number878.4800
Classification Product Code
GES  
Date Received10/06/1986
Decision Date 10/24/1986
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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