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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name connector, airway (extension)
510(k) Number K952824
Device Name NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
Applicant
INTERTEX MEDICAL, INC.
16 RIVER ST.
NEW CANAAN,  CT  06840
Applicant Contact CARY JENKINS
Correspondent
INTERTEX MEDICAL, INC.
16 RIVER ST.
NEW CANAAN,  CT  06840
Correspondent Contact CARY JENKINS
Regulation Number868.5810
Classification Product Code
BZA  
Date Received06/20/1995
Decision Date 07/20/1995
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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