Theia NPWT Foam Wound Dressing Kit

Negative Pressure Wound Therapy Powered Suction Pump

Clear Choice Therapeutics, Inc.

The following data is part of a premarket notification filed by Clear Choice Therapeutics, Inc. with the FDA for Theia Npwt Foam Wound Dressing Kit.

Pre-market Notification Details

Device IDK211277
510k NumberK211277
Device Name:Theia NPWT Foam Wound Dressing Kit
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Clear Choice Therapeutics, Inc. 530 W Cloverhurst Ave. Athens,  GA  30306
ContactBret Batchelder
CorrespondentKathy Herzog
DuVal & Associates 1820 Medical Arts Building, 820 Nicollet Mall Minneapolis,  MN  55402
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-27
Decision Date2021-12-16

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