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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name arterial blood sampling kit
510(k) Number K800860
Device Name OMNISTIK, MQ 501GS
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
109 Inverness Drive East
C1
Englewood,  CO  80112
Applicant Contact Donald L Bailey
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
109 Inverness Drive East
C1
Englewood,  CO  80112
Correspondent Contact Donald L Bailey
Regulation Number868.1100
Classification Product Code
CBT  
Date Received04/16/1980
Decision Date 04/29/1980
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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