The following data is part of a premarket notification filed by Unilene S.a.c. with the FDA for Vital Sutures Suturex Cirugia Peruana Sutumed.
| Device ID | K123034 |
| 510k Number | K123034 |
| Device Name: | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | UNILENE S.A.C. 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls UNILENE S.A.C. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | GAR |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-05-28 |