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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 K933947
Device Name LIFECARE CPAP-200
Applicant
Lifecare International,Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026 -9341
Applicant Contact HAROLD ELLERINGTON
Correspondent
Lifecare International,Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026 -9341
Correspondent Contact HAROLD ELLERINGTON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/12/1993
Decision Date 11/10/1994
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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