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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 K942299
Device Name ENDOCARE CRYOTHERAPY SYSTEM
Applicant
Cytocare, Inc.
100 Columbia, Suite 100
Aliso Viejo,  CA  92656
Applicant Contact MARK CHERNEY
Correspondent
Cytocare, Inc.
100 Columbia, Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact MARK CHERNEY
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/12/1994
Decision Date 01/19/1995
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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