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FDA 510(k) Application Details - K994231
Device Classification Name
Endoscopic Central Control Unit
More FDA Info for this Device
510(K) Number
K994231
Device Name
Endoscopic Central Control Unit
Applicant
SIEMENS MEDICAL CORP.
186 WOOD AVE. SOUTH
ISELIN, NJ 08830 US
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Contact
MALGORZATA STANEK
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
ODA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/1999
Decision Date
08/10/2000
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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