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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 K080969
Device Name HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
Applicant
Medi Nuclear Corp., Inc.
4610 Littlejohn St.
Baldwin Park,  CA  91706
Applicant Contact JERRY SCHOEN
Correspondent
Medi Nuclear Corp., Inc.
4610 Littlejohn St.
Baldwin Park,  CA  91706
Correspondent Contact JERRY SCHOEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/04/2008
Decision Date 07/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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