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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 K912043
Device Name ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
Applicant
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.1100
Classification Product Code
CBT  
Date Received05/08/1991
Decision Date 07/05/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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