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FDA 510(k) Application Details - K992901
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K992901
Device Name
Hysteroscope (And Accessories)
Applicant
GYNECARE, INC.
P.O. BOX 151
SOMMERVILLE, NJ 08876-0151 US
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Contact
GREGORY JONES
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
08/30/1999
Decision Date
01/18/2000
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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