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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K150518
Device Name Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
Applicant
DUPACO INC.
4144 AVENIDA DE LA PLATA
OCEANSIDE,  CA  92056
Applicant Contact AN VU
Correspondent
REGULATORY SPECIALIST, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number882.5070
Classification Product Code
JXL  
Subsequent Product Code
CAE  
Date Received03/02/2015
Decision Date 06/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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