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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K883833
Device Name NITRONOX(R), FIRST RESPONSE NITRONOX(TM)
Applicant
MATRIX MEDICA, INC.
145 MID COUNTY DR.
ORCHARD PARK,  NY 
Applicant Contact WYNNE, P.E.
Correspondent
MATRIX MEDICA, INC.
145 MID COUNTY DR.
ORCHARD PARK,  NY 
Correspondent Contact WYNNE, P.E.
Regulation Number868.5330
Classification Product Code
BZR  
Date Received09/09/1988
Decision Date 02/17/1989
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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