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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 K080657
Device Name NEB-90 LARGE VOLUME MEDICATION NEBULIZER
Applicant
MEDI NUCLEAR CORP., INC.
4610 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Applicant Contact MICHAEL MCPECK
Correspondent
MEDI NUCLEAR CORP., INC.
4610 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Correspondent Contact MICHAEL MCPECK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/07/2008
Decision Date 06/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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