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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K172208
Device Name NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
Applicant
Nevap, Inc.
975 Dionne Way
San Jose,  CA  95133
Applicant Contact Brenton Hanlon
Correspondent
Mae Consulting Group, LLC
119 N. Rd.
Deerfield,  NH  03037
Correspondent Contact Janet Kwiatkowski
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSR  
Date Received07/24/2017
Decision Date 02/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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