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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K813384
Device Name DISPOSABLE NEONATAL VENTILATION CIRCUIT
Applicant
INTEC.
22200 East 40 Highway
Blue Springs,  MO  64015
Applicant Contact J.W. Brown
Correspondent
INTEC.
22200 East 40 Highway
Blue Springs,  MO  64015
Correspondent Contact J.W. Brown
Regulation Number868.5975
Classification Product Code
BZO  
Date Received12/02/1981
Decision Date 01/07/1982
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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