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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 K983123
Device Name POC ENT ENDOSCOPE - SINUSCOPE
Applicant
PRECISION OPTICS CORP.
22 EAST BROADWAY
GARDNER,  MA  01440 -3338
Applicant Contact JAMES REILLY
Correspondent
PRECISION OPTICS CORP.
22 EAST BROADWAY
GARDNER,  MA  01440 -3338
Correspondent Contact JAMES REILLY
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/01/1998
Decision Date 09/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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