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510(k) K210310

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit by Nuance Medical, LLC — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2021
Date Received
February 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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