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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 K823936
Device Name CPAP INFANT NASAL CANNULAE SET
Applicant
Ackrad Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ackrad Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/29/1982
Decision Date 01/28/1983
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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