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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K893122
Device Name HEATED SERVO HUMIDIFIER, MODEL HDS 2
Applicant
Lifetronics, Inc.
2735 E. Beltline Rd.
Carrollton,  TX  75006
Applicant Contact DALE BICKLEY
Correspondent
Lifetronics, Inc.
2735 E. Beltline Rd.
Carrollton,  TX  75006
Correspondent Contact DALE BICKLEY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/25/1989
Decision Date 10/20/1989
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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