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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K945264
Device Name OPTUS OTOSCOPES
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 Number874.4770
Classification Product Code
ERA  
Date Received10/28/1994
Decision Date 02/02/1996
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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