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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 K102360
Device Name ICESENCE 3
Applicant
ICECURE MEDICAL LTD.
HAESHEL 7
CAESARIA,  IL 38900
Applicant Contact ELISABETH SADKA
Correspondent
ICECURE MEDICAL LTD.
HAESHEL 7
CAESARIA,  IL 38900
Correspondent Contact ELISABETH SADKA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/19/2010
Decision Date 11/29/2010
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
Recalls CDRH Recalls
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