Freeze’n Clear Skin Clinic Warts & Tags

Unit, Cryosurgical, Accessories

CryoConcepts LP

The following data is part of a premarket notification filed by Cryoconcepts Lp with the FDA for Freeze’n Clear Skin Clinic Warts & Tags.

Pre-market Notification Details

Device IDK211099
510k NumberK211099
Device Name:Freeze’n Clear Skin Clinic Warts & Tags
ClassificationUnit, Cryosurgical, Accessories
Applicant CryoConcepts LP 205 Webster St Bethlehem,  PA  18015
ContactSam Niedbala
CorrespondentSam Niedbala
CryoConcepts LP 205 Webster St Bethlehem,  PA  18015
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-13
Decision Date2022-06-17

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