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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 K012006
Device Name MEDICAL DEPOT POWER NEB 1
Applicant
Medical Depot, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ART WARD
Correspondent
Medical Depot, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ART WARD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/27/2001
Decision Date 07/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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