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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 K010991
Device Name SEEDNET, MODELS FP6T5, FP5T5, FP5T3
Applicant
Galil Medical , Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JOHATHAN S KAHAN
Correspondent
Galil Medical , Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JOHATHAN S KAHAN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/03/2001
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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