FDA 510(k) Application Details - K172956

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

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510(K) Number K172956
Device Name Applicator (Laryngo-Tracheal), Topical Anesthesia
Applicant Medica Holdings, LLC
5200 Meadows Rd Ste 150
Lake Oswego, OR 97035 US
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Contact George Reed
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Regulation Number 868.5170

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Classification Product Code CCT
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Date Received 09/26/2017
Decision Date 04/06/2018
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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