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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 K800023
FOIA Releasable 510(k) K800023
Device Name LUNG AEROSOL UNIT
Applicant
Cadema Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cadema Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
CAH  
Date Received01/07/1980
Decision Date 01/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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