The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Telavancin 30 Ug, Bbl Sensi-disc.
| Device ID | K100722 |
| 510k Number | K100722 |
| Device Name: | TELAVANCIN 30 UG, BBL SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks, MD 21152 |
| Contact | Janine Spafford |
| Correspondent | Janine Spafford Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks, MD 21152 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-15 |
| Decision Date | 2010-03-29 |
| Summary: | summary |