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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scalpel, one-piece
510(k) Number K854857
Device Name SCALPEL, ONE-PIECE, DISPOSABLE
Applicant
MEDELEC INTL. CORP.
ONE LINCOLN ROAD, SUITE 304
MIAMI BEACH,  FL  33139
Applicant Contact OSCAR D DOCAL
Correspondent
MEDELEC INTL. CORP.
ONE LINCOLN ROAD, SUITE 304
MIAMI BEACH,  FL  33139
Correspondent Contact OSCAR D DOCAL
Regulation Number878.4800
Classification Product Code
GDX  
Date Received12/05/1985
Decision Date 12/24/1985
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
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