FDA 510(k) Application Details - K061510

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K061510
Device Name Unit, Cryosurgical, Accessories
Applicant SANARUS MEDICAL, INC.
4696 WILLOW RD.
PLEASANTON, CA 94588 US
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Contact TRENA DEPEL
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 06/01/2006
Decision Date 07/18/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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