UNITOX BOTOX SYRINGE

Syringe, Piston

BIO-MED USA INC

The following data is part of a premarket notification filed by Bio-med Usa Inc with the FDA for Unitox Botox Syringe.

Pre-market Notification Details

Device IDK123710
510k NumberK123710
Device Name:UNITOX BOTOX SYRINGE
ClassificationSyringe, Piston
Applicant BIO-MED USA INC 111 ELLISON STREET Paterson,  NJ  07505
ContactYoung Chi
CorrespondentYoung Chi
BIO-MED USA INC 111 ELLISON STREET Paterson,  NJ  07505
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-04
Decision Date2013-05-09
Summary:summary

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