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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 K031908
Device Name MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)
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 Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
BTI  
Date Received06/20/2003
Decision Date 01/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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