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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 K890011
Device Name OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
Applicant
LIFE DESIGN SYSTEMS, INC.
5900 WEST FRANKLIN DR.
FRANKLIN,  WI  53132
Applicant Contact ALAN E WHITMARSH
Correspondent
LIFE DESIGN SYSTEMS, INC.
5900 WEST FRANKLIN DR.
FRANKLIN,  WI  53132
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5975
Classification Product Code
BZO  
Date Received01/03/1989
Decision Date 03/20/1989
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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