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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 K172041
Device Name truFreeze System
Applicant
CSA Medical, Inc.
91 Hartwell Avenue
Lexington,  MA  02421
Applicant Contact Sherrie Coval-Goldsmith
Correspondent
CSA Medical, Inc.
91 Hartwell Avenue
Lexington,  MA  02421
Correspondent Contact Sherrie Coval-Goldsmith
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/06/2017
Decision Date 07/27/2017
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
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