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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 PLAZA, P.O. BOX 6242
OCEANSIDE,  CA  92056
Applicant Contact DIMITRI G MONDIADIS
Correspondent
SABLE INDUSTRIES
COLLEGE PLAZA, 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
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