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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K770001
Device Name AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S
Applicant
Omnicon Medical Corp.
MO  11111 -
Correspondent
Omnicon Medical Corp.
MO  11111 -
Regulation Number868.5110
Classification Product Code
CAE  
Date Received01/03/1977
Decision Date 01/12/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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