The following data is part of a premarket notification filed by Unilene S.a.c. with the FDA for Vital Sutures, Suturex, Cirugia Peruana.
| Device ID | K100780 |
| 510k Number | K100780 |
| Device Name: | VITAL SUTURES, SUTUREX, CIRUGIA PERUANA |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | UNILENE S.A.C. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls, Rac |
| Correspondent | Kevin Walls, Rac UNILENE S.A.C. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | NEW |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAN |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07757093038375 | K100780 | 000 |
| 07757093036913 | K100780 | 000 |