FDA 510(k) Application Details - K954703

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K954703
Device Name Unit, Cryosurgical, Accessories
Applicant ELLMAN INTL., INC.
30 NORTHPORT RD.
SOUND BEACH, NY 11789-1734 US
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Contact RICHARD C LANZILLOTTO
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 10/12/1995
Decision Date 02/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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