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510(k) K172203

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray by Nuance Medical, LLC — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2017
Date Received
July 21, 2017
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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  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)
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