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FDA 510(k) Application Details - K983628
Device Classification Name
Light Source, Endoscope, Xenon Arc
More FDA Info for this Device
510(K) Number
K983628
Device Name
Light Source, Endoscope, Xenon Arc
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
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Contact
ROBERT L CASARSA
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCT
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More FDA Info for this Product Code
Date Received
10/15/1998
Decision Date
12/11/1998
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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