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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 K871314
Device Name CRYOSURGICAL PROBE
Applicant
Western Medical Research
217 N. Main St. Rm.205
Santa Ana,  CA  92701
Applicant Contact DAVID KEULEN
Correspondent
Western Medical Research
217 N. Main St. Rm.205
Santa Ana,  CA  92701
Correspondent Contact DAVID KEULEN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/01/1987
Decision Date 04/28/1987
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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