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FDA 510(k) Application Details - K994166
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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510(K) Number
K994166
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without 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
876.4300
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Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/1999
Decision Date
12/27/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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