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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drain, Tee (Water Trap)
510(k) Number K864147
Device Name AQUAVALVE
Applicant
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact PHYLLIS PIET-HUGHES
Correspondent
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact PHYLLIS PIET-HUGHES
Regulation Number868.5995
Classification Product Code
BYH  
Date Received10/22/1986
Decision Date 12/05/1986
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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