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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K934422
Device Name NASOPHARYNGOSCOPE
Applicant
MARKS & MURASE
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Applicant Contact GARY A ADLER
Correspondent
MARKS & MURASE
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Correspondent Contact GARY A ADLER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/13/1993
Decision Date 01/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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