FDA 510(k) Application Details - K002255

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

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510(K) Number K002255
Device Name Applicator (Laryngo-Tracheal), Topical Anesthesia
Applicant WOLFE TORY MEDICAL, INC.
79 WEST 4500 SOUTH, SUITE 21
SALT LAKE CITY, UT 84107 US
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Contact TIM WOLFE
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Regulation Number 868.5170

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Classification Product Code CCT
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Date Received 07/25/2000
Decision Date 09/18/2000
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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