FDA 510(k) Application Details - K963757

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K963757
Device Name Nasopharyngoscope (Flexible Or Rigid)
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 874.4760

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Classification Product Code EOB
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Date Received 09/18/1996
Decision Date 11/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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