The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Baxter Duplospray Mis Applicator.
| Device ID | K061092 |
| 510k Number | K061092 |
| Device Name: | BAXTER DUPLOSPRAY MIS APPLICATOR |
| Classification | Syringe, Piston |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Contact | Thomas Lopac |
| Correspondent | Thomas Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-19 |
| Decision Date | 2006-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020665 | K061092 | 000 |
| 10815634020617 | K061092 | 000 |
| 20815634020478 | K061092 | 000 |
| 20815634020485 | K061092 | 000 |
| 20815634020492 | K061092 | 000 |
| 20815634020577 | K061092 | 000 |
| 20815634020584 | K061092 | 000 |
| 00815634020641 | K061092 | 000 |
| 00815634020658 | K061092 | 000 |
| 10815634020594 | K061092 | 000 |