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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bronchoscope accessory
510(k) Number K153484
Device Name Dillard Airway Dilatation System
Applicant
INTUIT MEDICAL PRODUCTS, LLC
6018 EAGLES REST TRAIL
SUGAR HILL,  GA  30518
Applicant Contact JACK GRIFFIS
Correspondent
INTUIT MEDICAL PRODUCTS, LLC
6018 EAGLES REST TRAIL
SUGAR HILL,  GA  30518
Correspondent Contact JACK GRIFFIS
Regulation Number874.4680
Classification Product Code
KTI  
Date Received12/03/2015
Decision Date 07/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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