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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 K914778
Device Name NEOLINE(TM)
Applicant
MARTECH MEDICAL PRODUCTS, INC.
43223 BUSINESS PARK DR.
TEMECULA,  CA  92590
Applicant Contact MICHAEL D MARTELL
Correspondent
MARTECH MEDICAL PRODUCTS, INC.
43223 BUSINESS PARK DR.
TEMECULA,  CA  92590
Correspondent Contact MICHAEL D MARTELL
Regulation Number868.1100
Classification Product Code
CBT  
Date Received10/23/1991
Decision Date 09/16/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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