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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 K060928
Device Name CRYOSHAPE
Applicant
ETGAR GROUP H.M.Y.A. LTD.
37A ROTHSCHILD ST., 44449
KFAR-SABA,  IL
Applicant Contact BENNY ARAZY
Correspondent
ETGAR GROUP H.M.Y.A. LTD.
37A ROTHSCHILD ST., 44449
KFAR-SABA,  IL
Correspondent Contact BENNY ARAZY
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/04/2006
Decision Date 05/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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