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FDA 510(k) Application Details - K132181
Device Classification Name
Dilator, Catheter, Ureteral
More FDA Info for this Device
510(K) Number
K132181
Device Name
Dilator, Catheter, Ureteral
Applicant
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
136 TURNPIKE ROAD
SOUTHBOROUGH, MA 01772 US
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Contact
NEIL KELLY
Other 510(k) Applications for this Contact
Regulation Number
876.5470
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Classification Product Code
EZN
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More FDA Info for this Product Code
Date Received
07/15/2013
Decision Date
10/21/2013
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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