FDA 510(k) Application Details - K093584

Device Classification Name Applicator (Laryngo-Tracheal), Topical Anesthesia

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510(K) Number K093584
Device Name Applicator (Laryngo-Tracheal), Topical Anesthesia
Applicant N.M. BEALE CO. INC.
5 WHITCOMB AVENUE
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 868.5170

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Classification Product Code CCT
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Date Received 11/19/2009
Decision Date 03/04/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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