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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 K090851
Device Name DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
Applicant
Byrne Medical, Inc.
3150 Pollok Dr.
Conroe,  TX  77303
Applicant Contact JENNIFER JAMES
Correspondent
Byrne Medical, Inc.
3150 Pollok Dr.
Conroe,  TX  77303
Correspondent Contact JENNIFER JAMES
Regulation Number876.1500
Classification Product Code
ODC  
Date Received03/30/2009
Decision Date 07/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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