RANDALL CURETTE

Curette, Surgical, General Use

EURO-MED INTL.

The following data is part of a premarket notification filed by Euro-med Intl. with the FDA for Randall Curette.

Pre-market Notification Details

Device IDK854888
510k NumberK854888
Device Name:RANDALL CURETTE
ClassificationCurette, Surgical, General Use
Applicant EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville,  CA  94526
ContactDonald Holsted
CorrespondentDonald Holsted
EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville,  CA  94526
Product CodeFZS  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-06
Decision Date1985-12-24

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