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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 K954015
Device Name ABG POINT LOK NEEDLE PROTECTION DEVICE
Applicant
DEVON INDUSTRIES, INC.
9530 DESOTO AVE.
CHATSWORTH,  CA  91311 -5084
Applicant Contact GEORGE AUSTRIA
Correspondent
DEVON INDUSTRIES, INC.
9530 DESOTO AVE.
CHATSWORTH,  CA  91311 -5084
Correspondent Contact GEORGE AUSTRIA
Regulation Number868.1100
Classification Product Code
CBT  
Date Received08/25/1995
Decision Date 11/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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