Ultrast Gel

Media, Coupling, Ultrasound

Ultrast, Inc.

The following data is part of a premarket notification filed by Ultrast, Inc. with the FDA for Ultrast Gel.

Pre-market Notification Details

Device IDK211691
510k NumberK211691
Device Name:Ultrast Gel
ClassificationMedia, Coupling, Ultrasound
Applicant Ultrast, Inc. 3286 Balsam St Oceanside,  NY  11572
ContactHoward Levine
CorrespondentHoward Levine
Ultrast, Inc. 3286 Balsam St Oceanside,  NY  11572
Product CodeMUI  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-02
Decision Date2021-12-22

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