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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condenser, heat and moisture (artificial nose)
510(k) Number K885313
Device Name HUMIDI-FLEX TM
Applicant
LIFE DESIGN SYSTEMS, INC.
5900 WEST FRANKLIN DR.
FRANKLIN,  WI  53132
Applicant Contact ALAN WHITMARSH
Correspondent
LIFE DESIGN SYSTEMS, INC.
5900 WEST FRANKLIN DR.
FRANKLIN,  WI  53132
Correspondent Contact ALAN WHITMARSH
Regulation Number868.5375
Classification Product Code
BYD  
Date Received12/29/1988
Decision Date 10/11/1989
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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