CRYO Arctic, CRYO Penguin

Vapocoolant Device

CryoScience North America, Inc.

The following data is part of a premarket notification filed by Cryoscience North America, Inc. with the FDA for Cryo Arctic, Cryo Penguin.

Pre-market Notification Details

Device IDK203661
510k NumberK203661
Device Name:CRYO Arctic, CRYO Penguin
ClassificationVapocoolant Device
Applicant CryoScience North America, Inc. 401 Louisuana St, 8th Floor Houston,  TX  77002 -1629
ContactGreg Nehrlich
CorrespondentRobert Seiple
QPM Consulting, LLC 3817 Seville Rd Denton,  TX  76205
Product CodeMLY  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-15
Decision Date2022-05-25

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