FDA 510(k) Application Details - K982506

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K982506
Device Name Unit, Cryosurgical, Accessories
Applicant CRYOSURGERY, INC.
P.O. BOX 50035
NASHVILLE, TN 37205-0035 US
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Contact RONALD A MCDOW
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 07/20/1998
Decision Date 01/27/1999
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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