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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 K915075
Device Name NEBULIZER (DIRECT PATIENT INTERFACE)
Applicant
Medi Nuclear Corp., Inc.
4501 Littlejohn St.
Baldwin Park,  CA  91706
Applicant Contact RUSSELL W.KING
Correspondent
Medi Nuclear Corp., Inc.
4501 Littlejohn St.
Baldwin Park,  CA  91706
Correspondent Contact RUSSELL W.KING
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/08/1991
Decision Date 07/16/1992
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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