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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K102409
FOIA Releasable 510(k) K102409
Device Name DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
Applicant
Byrne Medical, Inc.
3150 Pollok Dr.
Conroe,  TX  77303
Applicant Contact JOHN WILLIS
Correspondent
Byrne Medical, Inc.
3150 Pollok Dr.
Conroe,  TX  77303
Correspondent Contact JOHN WILLIS
Regulation Number876.1500
Classification Product Code
ODC  
Subsequent Product Code
FDF  
Date Received08/24/2010
Decision Date 11/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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