The following data is part of a premarket notification filed by Baxter Healthcare Corp., Bioscience with the FDA for Easyspray And Spray Set For Tisseel (fiber Sealant).
| Device ID | K050495 |
| 510k Number | K050495 |
| Device Name: | EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) |
| Classification | Syringe, Piston |
| Applicant | BAXTER HEALTHCARE CORP., BIOSCIENCE ONE BAXTER WAY Westlake Village, CA 91362 |
| Contact | Ron Lagerquist |
| Correspondent | Ron Lagerquist BAXTER HEALTHCARE CORP., BIOSCIENCE ONE BAXTER WAY Westlake Village, CA 91362 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05413760499055 | K050495 | 000 |
| 55413765583433 | K050495 | 000 |