FDA 510(k) Application Details - K072883

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K072883
Device Name Unit, Cryosurgical, Accessories
Applicant ARBEL MEDICAL LTD.
990 WASHINGTON ST.
DEDHAM, MA 02026 US
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Contact ZVI LADIN
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 10/09/2007
Decision Date 12/10/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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