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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K820878
Device Name CONCHO PEDIATRIC PACK
Applicant
RCI, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RCI, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/30/1982
Decision Date 05/03/1982
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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