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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 K080622
Device Name ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
Applicant
OPTIM, INC.
64 TECHNOLOGY PARK RD.
STURBRIDGE,  MA  01566 -1262
Applicant Contact ROBERT KRUPA
Correspondent
OPTIM, INC.
64 TECHNOLOGY PARK RD.
STURBRIDGE,  MA  01566 -1262
Correspondent Contact ROBERT KRUPA
Regulation Number874.4760
Classification Product Code
EOB  
Date Received03/05/2008
Decision Date 04/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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