510(k) K981089
K981089 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "TISSOMAT AND SPRAY SET". The FDA issued a decision of Substantially Equivalent on Jul 5, 2000. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 5, 2000
- Date Received
- Mar 25, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)