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FDA 510(k) Application Details - K974775
Device Classification Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
More FDA Info for this Device
510(K) Number
K974775
Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Applicant
AIRTRONIC SERVICES, INC.
116 NORTH LIVELY BLVD.
ELK GROVE VILLAGE, IL 60007 US
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Contact
ROBERT E WALTER
Other 510(k) Applications for this Contact
Regulation Number
876.1620
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Classification Product Code
FAP
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More FDA Info for this Product Code
Date Received
12/22/1997
Decision Date
02/19/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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