The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Deklene Maxx.
| Device ID | K193530 |
| 510k Number | K193530 |
| Device Name: | Deklene MAXX |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Robin Haden |
| Correspondent | Robin Haden Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-03-19 |