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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 K133258
Device Name TRUFREEZE SYSTEM
Applicant
CSA Medical, Inc.
91 Hartwell Ave.
Lexington,  MA  02421
Applicant Contact ELLEN SHEETS, MD, MBA
Correspondent
CSA Medical, Inc.
91 Hartwell Ave.
Lexington,  MA  02421
Correspondent Contact ELLEN SHEETS, MD, MBA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received10/23/2013
Decision Date 06/19/2014
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
Recalls CDRH Recalls
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