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FDA 510(k) Application Details - K963872
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K963872
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE, CA 94089 US
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Contact
MICHAEL A DANIEL
Other 510(k) Applications for this Contact
Regulation Number
884.1720
More FDA Info for this Regulation Number
Classification Product Code
HET
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More FDA Info for this Product Code
Date Received
09/26/1996
Decision Date
01/17/1997
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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