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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubing, pressure and accessories
510(k) Number K943110
Device Name GAS SAMPLING INTERFACES
Applicant
COAST MEDICAL, INC.
1060-H NORTH BATAVIA
ORANGE,  CA  92867
Applicant Contact DOUGLAS R MONGEON
Correspondent
COAST MEDICAL, INC.
1060-H NORTH BATAVIA
ORANGE,  CA  92867
Correspondent Contact DOUGLAS R MONGEON
Regulation Number868.5860
Classification Product Code
BYX  
Date Received06/29/1994
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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