Picore

Powered Laser Surgical Instrument

Bio-Med USA Inc

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

Pre-market Notification Details

Device IDK212082
510k NumberK212082
Device Name:Picore
ClassificationPowered Laser Surgical Instrument
Applicant Bio-Med USA Inc 27 New England Dr Ramsey,  NJ  07446
ContactYoung Chi
CorrespondentYoung Chi
Bio-Med USA Inc 27 New England Dr Ramsey,  NJ  07446
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-02
Decision Date2021-10-06

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