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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 K030747
Device Name PRODOSE AAD SYSTEM
Applicant
Profile Therapeutics Plc
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
Profile Therapeutics Plc
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/10/2003
Decision Date 04/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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