SurgiWrap FROST

Mesh, Surgical, Polymeric

MAST Biosurgery

The following data is part of a premarket notification filed by Mast Biosurgery with the FDA for Surgiwrap Frost.

Pre-market Notification Details

Device IDK200918
510k NumberK200918
Device Name:SurgiWrap FROST
ClassificationMesh, Surgical, Polymeric
Applicant MAST Biosurgery 6749 Top Gun St. Suite 108 San Diego,  CA  92121
ContactRoel Trip
CorrespondentKenneth K. Kleinhenz
QSR Consulting 10807 Dakota Ranch Rd. Santee,  CA  92071
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2021-01-07

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