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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 K830310
Device Name OMNISTICK
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
112 Inverness Circle
Suite A
Englewood,  CO  80112
Applicant Contact Mary Steggall
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
112 Inverness Circle
Suite A
Englewood,  CO  80112
Correspondent Contact Mary Steggall
Regulation Number868.1100
Classification Product Code
CBT  
Date Received01/26/1983
Decision Date 05/25/1983
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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