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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K153489
Device Name Cryocare CS Surgical System
Applicant
Healthtronics
9825 Spectrum Dr.
Austin,  TX  78717
Applicant Contact Maritza Ward
Correspondent
Healthtronics
9825 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact Maritza Ward
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/04/2015
Decision Date 02/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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