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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K041974
Device Name MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
Applicant
MED2000 S.R.L.
55 NORTHERN BLVD., STE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
MED2000 S.R.L.
55 NORTHERN BLVD., STE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.6250
Classification Product Code
BTI  
Date Received07/22/2004
Decision Date 08/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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