The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Tissomat And Spray Set.
| Device ID | K981089 |
| 510k Number | K981089 |
| Device Name: | TISSOMAT AND SPRAY SET |
| Classification | Syringe, Piston |
| Applicant | BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. Glendale, CA 91023 |
| Contact | Angela Blackshere |
| Correspondent | Angela Blackshere BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. Glendale, CA 91023 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-25 |
| Decision Date | 2000-07-05 |
| Summary: | summary |