The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Dekna-lok Model Bp1000v2l.
| Device ID | K060801 |
| 510k Number | K060801 |
| Device Name: | DEKNA-LOK MODEL BP1000V2L |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | TELEFLEX MEDICAL 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | Kimberly Edgerton |
| Correspondent | Kimberly Edgerton TELEFLEX MEDICAL 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-24 |
| Decision Date | 2006-05-17 |
| Summary: | summary |