Barrigel Injectable Gel

Hydrogel Spacer

Palette Life Sciences

The following data is part of a premarket notification filed by Palette Life Sciences with the FDA for Barrigel Injectable Gel.

Pre-market Notification Details

Device IDK220641
510k NumberK220641
Device Name:Barrigel Injectable Gel
ClassificationHydrogel Spacer
Applicant Palette Life Sciences 27 East Cota Street, Suite 402 Santa Barbara,  CA  93101
ContactDavid Goodnough
CorrespondentDavid Goodnough
Palette Life Sciences 27 East Cota Street, Suite 402 Santa Barbara,  CA  93101
Product CodeOVB  
CFR Regulation Number892.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-05-26

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