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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K802477
Device Name MISTY NEBULIZER
Applicant
AIRLIFE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AIRLIFE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/05/1980
Decision Date 10/31/1980
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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