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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 K042546
Device Name FUNHALER, MODEL FH 101
Applicant
INFAMED LTD.
20310 SW 48TH STREET
FORT LAUDERDALE,  FL  33332
Applicant Contact JOHN D GREENBAUM
Correspondent
INFAMED LTD.
20310 SW 48TH STREET
FORT LAUDERDALE,  FL  33332
Correspondent Contact JOHN D GREENBAUM
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/20/2004
Decision Date 01/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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