The following data is part of a premarket notification filed by Ace Medical Us, Llc with the FDA for Modification To Autofuser.
| Device ID | K090300 |
| 510k Number | K090300 |
| Device Name: | MODIFICATION TO AUTOFUSER |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | ACE MEDICAL US, LLC 9102 TURFWAY BEND DR. Powell, OH 43065 |
| Contact | Andrew Lamborne |
| Correspondent | Andrew Lamborne ACE MEDICAL US, LLC 9102 TURFWAY BEND DR. Powell, OH 43065 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25060112312902 | K090300 | 000 |
| 25060112312216 | K090300 | 000 |
| 25060112312148 | K090300 | 000 |
| 24026704647655 | K090300 | 000 |
| 24026704647648 | K090300 | 000 |
| 24026704647631 | K090300 | 000 |
| 24026704647624 | K090300 | 000 |
| 24026704647600 | K090300 | 000 |
| 24026704612318 | K090300 | 000 |
| 24026704612301 | K090300 | 000 |
| 24026704612295 | K090300 | 000 |
| 24026704647617 | K090300 | 000 |
| 24026704743548 | K090300 | 000 |
| 24026704743531 | K090300 | 000 |
| 24026704743524 | K090300 | 000 |
| 24026704743517 | K090300 | 000 |
| 24026704743500 | K090300 | 000 |
| 24026704743494 | K090300 | 000 |
| 25060112312292 | K090300 | 000 |
| 25060112312452 | K090300 | 000 |
| 25060112312490 | K090300 | 000 |
| 25060112312896 | K090300 | 000 |
| 25060112312889 | K090300 | 000 |
| 25060112312872 | K090300 | 000 |
| 25060112312865 | K090300 | 000 |
| 25060112312858 | K090300 | 000 |
| 25060112312841 | K090300 | 000 |
| 25060112312834 | K090300 | 000 |
| 25060112312827 | K090300 | 000 |
| 25060112312803 | K090300 | 000 |
| 25060112312797 | K090300 | 000 |
| 25060112312780 | K090300 | 000 |
| 25060112312773 | K090300 | 000 |
| 25060112312759 | K090300 | 000 |
| 25060112312704 | K090300 | 000 |
| 25060112312629 | K090300 | 000 |
| 25060112312612 | K090300 | 000 |
| 25060112312582 | K090300 | 000 |
| 24026704743470 | K090300 | 000 |