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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 K904421
Device Name CMS ONCOPROBE (TM)
Applicant
Cryomedical Sciences, Inc.
Three Bethesda Metro Cdenter
Suite 700
Bethesda,  MD  20814
Applicant Contact FINKELSTIEN
Correspondent
Cryomedical Sciences, Inc.
Three Bethesda Metro Cdenter
Suite 700
Bethesda,  MD  20814
Correspondent Contact FINKELSTIEN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/27/1990
Decision Date 04/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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