FDA 510(k) Application Details - K955176

Device Classification Name Unit, Electrosurgical, And Accessories, Dental

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510(K) Number K955176
Device Name Unit, Electrosurgical, And Accessories, Dental
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 872.4920

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Classification Product Code EKZ
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Date Received 11/13/1995
Decision Date 04/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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