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510(k) K161337

CryoDose H or Similar by Nuance Medical, LLC — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2016
Date Received
May 13, 2016
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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