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FDA 510(k) Application Details - K061937
Device Classification Name
Dilator, Esophageal
More FDA Info for this Device
510(K) Number
K061937
Device Name
Dilator, Esophageal
Applicant
COOK ENDOSCOPY
4900 BETHANIA STATION RD.
WINSTON-SALEM, NC 27105 US
Other 510(k) Applications for this Company
Contact
MABEL L HUNTER
Other 510(k) Applications for this Contact
Regulation Number
876.5365
More FDA Info for this Regulation Number
Classification Product Code
KNQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/10/2006
Decision Date
12/01/2006
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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