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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K844179
Device Name LP-5
Applicant
Life Products, Inc.
2545 Central Ave.
Boulder,  CO  80301
Applicant Contact RICHARD APPLE
Correspondent
Life Products, Inc.
2545 Central Ave.
Boulder,  CO  80301
Correspondent Contact RICHARD APPLE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/26/1984
Decision Date 01/18/1985
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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