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510(k) K190407

CryoLab by Cryoconcepts LP — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2019
Date Received
February 21, 2019
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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