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FDA 510(k) Application Details - K954774
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
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510(K) Number
K954774
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
GABRIS SURGICAL CORP.
1432 NORTH GREAT NECK RD.,
SUITE 204
VIRGINIA BEACH, VA 23454 US
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Contact
BARBARA E KENNY
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Regulation Number
884.1720
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Classification Product Code
HET
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More FDA Info for this Product Code
Date Received
10/17/1995
Decision Date
06/07/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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