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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 K141747
Device Name RHINOGUARD
Applicant
DAVIS MEDICAL
12602 N. SUMMER WIND DRIVE
MARANA,  AZ  85658
Applicant Contact MICHELLE LOTT
Correspondent
DAVIS MEDICAL
12602 N. SUMMER WIND DRIVE
MARANA,  AZ  85658
Correspondent Contact MICHELLE LOTT
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/30/2014
Decision Date 04/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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