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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 K072651
Device Name CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
Applicant
CSA Medical, Inc.
1101 E. 33rd St.
Third Floor - #E305
Baltimore,  MD  21218
Applicant Contact JENNIFER CARTLEDGE
Correspondent
CSA Medical, Inc.
1101 E. 33rd St.
Third Floor - #E305
Baltimore,  MD  21218
Correspondent Contact JENNIFER CARTLEDGE
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/19/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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