SCALPEL, ONE-PIECE, DISPOSABLE

Scalpel, One-piece

MEDELEC INTL. CORP.

The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Scalpel, One-piece, Disposable.

Pre-market Notification Details

Device IDK854857
510k NumberK854857
Device Name:SCALPEL, ONE-PIECE, DISPOSABLE
ClassificationScalpel, One-piece
Applicant MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach,  FL  33139
ContactOscar D Docal
CorrespondentOscar D Docal
MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach,  FL  33139
Product CodeGDX  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-05
Decision Date1985-12-24

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