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FDA 510(k) Application Details - K072594
Device Classification Name
Kit, Nephroscope
More FDA Info for this Device
510(K) Number
K072594
Device Name
Kit, Nephroscope
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772 US
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Contact
GRAHAM A BAILLIE
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Regulation Number
876.1500
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Classification Product Code
FGA
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More FDA Info for this Product Code
Date Received
09/14/2007
Decision Date
12/13/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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