FDA 510(k) Application Details - K983123

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K983123
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant PRECISION OPTICS CORP.
22 EAST BROADWAY
GARDNER, MA 01440-3338 US
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Contact JAMES REILLY
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 07/01/1998
Decision Date 09/25/1998
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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