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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 K944656
Device Name OPTUS SINUSCOPES AND ACCESSORIES
Applicant
OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER,  CO  80231
Applicant Contact PETER DUFFY
Correspondent
OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER,  CO  80231
Correspondent Contact PETER DUFFY
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/21/1994
Decision Date 01/26/1995
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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