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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 K881638
Device Name SURGICAL BLADE
Applicant
FAR EAST INTL. TRADING CORP.
727 N. BROADWAY, SUITE 101
LOS ANGELES,  CA  90012
Applicant Contact JULIA SUN
Correspondent
FAR EAST INTL. TRADING CORP.
727 N. BROADWAY, SUITE 101
LOS ANGELES,  CA  90012
Correspondent Contact JULIA SUN
Regulation Number878.4800
Classification Product Code
GES  
Date Received04/14/1988
Decision Date 06/15/1988
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
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