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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 K943717
Device Name MASTER-NEB NEBULIZER COMPRESSOR SYSTEM
Applicant
Howard K. Mann & Assoc.
7 Kester Dr.
Edison,  NJ  08817
Applicant Contact HOWARD K MANN
Correspondent
Howard K. Mann & Assoc.
7 Kester Dr.
Edison,  NJ  08817
Correspondent Contact HOWARD K MANN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/01/1994
Decision Date 09/12/1995
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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