The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Baxter Duplotip Surgical Sealant Applicator.
| Device ID | K033589 |
| 510k Number | K033589 |
| Device Name: | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR |
| Classification | Syringe, Piston |
| Applicant | MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Contact | Charles K Grote |
| Correspondent | Charles K Grote MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-11-13 |
| Decision Date | 2004-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815634020560 | K033589 | 000 |
| 10815634021263 | K033589 | 000 |
| 00815634020092 | K033589 | 000 |
| 10815634020105 | K033589 | 000 |
| 00815634020115 | K033589 | 000 |
| 00815634020122 | K033589 | 000 |
| 00815634020139 | K033589 | 000 |
| 00815634020146 | K033589 | 000 |
| 20815634020515 | K033589 | 000 |
| 20815634020522 | K033589 | 000 |
| 20815634020539 | K033589 | 000 |
| 20815634020546 | K033589 | 000 |
| 20815634020553 | K033589 | 000 |
| 10815634020761 | K033589 | 000 |