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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K891124
Device Name NON-REBREATHING AIRWAY AND MASK(S) KITS
Applicant
Airway Products, Inc.
710 Main St. - Suite L
Blue Springs,  MO  64015 -2934
Applicant Contact KEITH W SHEPARD
Correspondent
Airway Products, Inc.
710 Main St. - Suite L
Blue Springs,  MO  64015 -2934
Correspondent Contact KEITH W SHEPARD
Regulation Number868.5870
Classification Product Code
CBP  
Date Received03/03/1989
Decision Date 10/13/1989
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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