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FDA 510(k) Application Details - K080764
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K080764
Device Name
Endoscope Channel Accessory
Applicant
MAX ENDOSCOPY INC.
1410 HIGHLAND ROAD, SUITE 6
MACEDONIA, OH 44056 US
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Contact
RICHARD M WOLF
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
ODC
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More FDA Info for this Product Code
Date Received
03/18/2008
Decision Date
05/06/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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