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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 K891586
Device Name ORAL AIRWAY
Applicant
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Applicant Contact MARVIN D SCHATTNER
Correspondent
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Correspondent Contact MARVIN D SCHATTNER
Regulation Number868.5110
Classification Product Code
CAE  
Date Received03/20/1989
Decision Date 05/11/1989
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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