FDA 510(k) Application Details - K160239

Device Classification Name

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510(K) Number K160239
Device Name TAP 3, TAP 1
Applicant Airway Management, Inc.
3418 Midcourt Road, Ste. 114
Carrollton, TX 75006 US
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Contact Dale Siebenmorgen
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Regulation Number

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Classification Product Code PLC
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Date Received 02/01/2016
Decision Date 08/10/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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