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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laryngoscope, rigid
510(k) Number K945269
Device Name OPTUS LARYNGOSCOPES
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 Number868.5540
Classification Product Code
CCW  
Date Received10/28/1994
Decision Date 11/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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