Dressing, Wound, Drug

Acera Surgical, Inc.

The following data is part of a premarket notification filed by Acera Surgical, Inc. with the FDA for Restrata®.

Pre-market Notification Details

Device IDK193583
510k NumberK193583
Device Name:Restrata®
ClassificationDressing, Wound, Drug
Applicant Acera Surgical, Inc. 10880 Baur Blvd. St. Louis,  MO  63132
ContactLily Jeng
CorrespondentLinda Braddon
Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-09-25

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