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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 K143625
Device Name truFreeze System
Applicant
CSA MEDICAL, INC.
91 HARTWELL AVE
LEXINGTON,  MA  02421
Applicant Contact SHERRIE COVAL-GOLDSMITH
Correspondent
CSA MEDICAL, INC.
91 HARTWELL AVE
LEXINGTON,  MA  02421
Correspondent Contact SHERRIE COVAL-GOLDSMITH
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/22/2014
Decision Date 01/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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