The following data is part of a premarket notification filed by Profile Therapeutics Plc with the FDA for Prodose Aad System.
Device ID | K030747 |
510k Number | K030747 |
Device Name: | PRODOSE AAD SYSTEM |
Classification | Nebulizer (direct Patient Interface) |
Applicant | PROFILE THERAPEUTICS PLC 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Contact | Paul Dryden |
Correspondent | Paul Dryden PROFILE THERAPEUTICS PLC 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-10 |
Decision Date | 2004-04-22 |
Summary: | summary |