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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 K860659
Device Name END TIDAL CO2 SAMPLING CIRCUIT
Applicant
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Applicant Contact GILBERT M KIRK
Correspondent
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Correspondent Contact GILBERT M KIRK
Regulation Number868.5975
Classification Product Code
BZO  
Date Received02/24/1986
Decision Date 04/17/1986
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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