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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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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