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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K871669
Device Name BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
Applicant
Life Design Systems, Inc.
5900 W. Franklin Dr.
Franklin,  WI  53132
Applicant Contact ALAN E WHITMARSH
Correspondent
Life Design Systems, Inc.
5900 W. Franklin Dr.
Franklin,  WI  53132
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5240
Classification Product Code
CAI  
Date Received04/28/1987
Decision Date 05/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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