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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, External Body, Negative Pressure, Adult (Cuirass)
510(k) Number K910947
Device Name NEV-10 NEGATIVE PRESSURE VENTILATOR
Applicant
Lifecare Services, Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026
Applicant Contact HAROLD ELLERINGTON
Correspondent
Lifecare Services, Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026
Correspondent Contact HAROLD ELLERINGTON
Regulation Number868.5935
Classification Product Code
BYT  
Date Received03/06/1991
Decision Date 06/03/1991
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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