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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 -4114
Applicant Contact MARK CHERNEY
Correspondent
CYTOCARE, INC.
100 COLUMBIA
SUITE 100
ALISO VIEJO,  CA  92656 -4114
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
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