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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K895592
Device Name FREEWAY NEBULIZER COMPRESSOR
Applicant
LIFECARE SERVICES, INC.
655 ASPEN RIDGE DR.
LAFAYETTE,  CO  80026
Applicant Contact R ELLERINGTON
Correspondent
LIFECARE SERVICES, INC.
655 ASPEN RIDGE DR.
LAFAYETTE,  CO  80026
Correspondent Contact R ELLERINGTON
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received09/15/1989
Decision Date 11/21/1989
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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