FDA 510(k) Application Details - K011950

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K011950
Device Name Unit, Cryosurgical, Accessories
Applicant GALIL MEDICAL LTD.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 06/21/2001
Decision Date 01/29/2002
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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