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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
Applicant Contact ROBERT KRUPA
Correspondent
Optim, Inc.
64 Technology Park Rd.
Sturbridge,  MA  01566
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
Predetermined Change
Control Plan Authorized		 No
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