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FDA 510(k) Application Details - K982771
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K982771
Device Name
Hysteroscope (And Accessories)
Applicant
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF CF3 0LT GB
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Contact
DAVID KAY
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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
08/07/1998
Decision Date
01/21/1999
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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