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FDA 510(k) Application Details - K982965
Device Classification Name
Camera, Television, Endoscopic, Without Audio
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510(K) Number
K982965
Device Name
Camera, Television, Endoscopic, Without Audio
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
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Contact
ROBERT L CASARSA
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Regulation Number
878.4160
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Classification Product Code
FWF
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More FDA Info for this Product Code
Date Received
08/25/1998
Decision Date
11/23/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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