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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 K871403
Device Name MODIFIED C.P.R. MICROSHIELD
Applicant
WESTMARK ENTERPRISES, INC.
8710 TRUMBULL AVE.
SKOKIE,  IL  60076
Applicant Contact MARK D WESTFALL
Correspondent
WESTMARK ENTERPRISES, INC.
8710 TRUMBULL AVE.
SKOKIE,  IL  60076
Correspondent Contact MARK D WESTFALL
Regulation Number868.5110
Classification Product Code
CAE  
Date Received04/08/1987
Decision Date 05/04/1987
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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