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510(k) K153489

Cryocare CS Surgical System by Healthtronics — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
December 4, 2015
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

Other clearances by Healthtronics

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  • K141110 — CRYOCARE CS SURGICAL SYSTEM (June 25, 2015)
  • K021775 — LTFS230 (December 23, 2002)

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