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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 K861555
Device Name CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
Applicant
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact WILKE
Correspondent
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact WILKE
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/25/1986
Decision Date 06/05/1986
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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