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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 K955721
Device Name CUFFED OROPHARYNGEAL AIRWAY (COPA)
Applicant
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact ROBERT A BIRAG
Correspondent
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact ROBERT A BIRAG
Regulation Number868.5110
Classification Product Code
CAE  
Date Received12/18/1995
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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