FDA 510(k) Application Details - K110088

Device Classification Name Endoscope Channel Accessory

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510(K) Number K110088
Device Name Endoscope Channel Accessory
Applicant BYRNE MEDICAL INCORPORATED
3150 Pollok Drive
Conroe, TX 77303 US
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Contact JOHN WILLIS
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Regulation Number 876.1500

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Classification Product Code ODC
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Date Received 01/12/2011
Decision Date 06/10/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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