FLEX-I-GRASP

Arthroscope

EURO-MED INTL.

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

Pre-market Notification Details

Device IDK854889
510k NumberK854889
Device Name:FLEX-I-GRASP
ClassificationArthroscope
Applicant EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville,  CA  94526
ContactDonald Holsten
CorrespondentDonald Holsten
EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville,  CA  94526
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-06
Decision Date1986-02-21

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