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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K910239
Device Name NEBU-SOL METERED DOSE DISPENSER (TM)
Applicant
Dey Laboratories, Inc.
2751 Napa Valley Corporate
Drive
Napa,  CA  94558
Applicant Contact ALLAN M RAFF
Correspondent
Dey Laboratories, Inc.
2751 Napa Valley Corporate
Drive
Napa,  CA  94558
Correspondent Contact ALLAN M RAFF
Regulation Number868.6810
Classification Product Code
BSY  
Date Received01/22/1991
Decision Date 05/22/1991
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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