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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 K042667
Device Name SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
Applicant
Galil Medical , Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHN
Correspondent
Galil Medical , Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHN
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received09/29/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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