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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 K003344
Device Name MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
Applicant
MEDICAL DEPOT, INC.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Applicant Contact ART WARD
Correspondent
MEDICAL DEPOT, INC.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Correspondent Contact ART WARD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/25/2000
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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