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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K912224
Device Name LIFECARE CPAP-100
Applicant
LIFECARE SERVICES, INC.
655 ASPEN RIDGE DR.
LAFAYETTE,  CO  80026
Applicant Contact HAROLD R.ELLERINGTON
Correspondent
LIFECARE SERVICES, INC.
655 ASPEN RIDGE DR.
LAFAYETTE,  CO  80026
Correspondent Contact HAROLD R.ELLERINGTON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/20/1991
Decision Date 09/23/1991
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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