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FDA 510(k) Application Details - K994418
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K994418
Device Name
Hysteroscope (And Accessories)
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
Other 510(k) Applications for this Company
Contact
GREGORY JONES
Other 510(k) Applications for this Contact
Regulation Number
884.1690
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Classification Product Code
HIH
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More FDA Info for this Product Code
Date Received
12/29/1999
Decision Date
01/24/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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