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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 K945719
Device Name ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Applicant Contact K M KROEHNKE
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Correspondent Contact K M KROEHNKE
Regulation Number868.1100
Classification Product Code
CBT  
Date Received11/21/1994
Decision Date 03/16/1995
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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