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510(k) K203661

CRYO Arctic, CRYO Penguin by Cryoscience North America, Inc. — Product Code MLY

K203661 is an FDA 510(k) premarket notification submitted by Cryoscience North America, Inc. for the device "CRYO Arctic, CRYO Penguin". The FDA issued a decision of Substantially Equivalent on May 25, 2022. The device falls under product code MLY (Vapocoolant Device), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2022
Date Received
December 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)
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FDA data resources