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FDA 510(k) Application Details - K141515
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K141515
Device Name
Hysteroscope (And Accessories)
Applicant
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
22134 SHERMAN WAY
CANOGA PARK, CA 91303 US
Other 510(k) Applications for this Company
Contact
GAYLE BUTLER
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
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More FDA Info for this Product Code
Date Received
06/09/2014
Decision Date
01/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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