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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 K780562
Device Name AQUAPAK PREFILLED HUMIDIFIER
Applicant
RESPIRATORY CARE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RESPIRATORY CARE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/07/1978
Decision Date 04/27/1978
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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