The following data is part of a premarket notification filed by Serral, S.a. De C.v. with the FDA for Serralene, Model Catalog No 1s.
| Device ID | K020265 |
| 510k Number | K020265 |
| Device Name: | SERRALENE, MODEL CATALOG NO 1S |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | SERRAL, S.A. DE C.V. 5251-18 JOHN TYLER HWY, SUITE 167 Williamsburg, VA 23185 |
| Contact | Scott Henderson |
| Correspondent | Scott Henderson SERRAL, S.A. DE C.V. 5251-18 JOHN TYLER HWY, SUITE 167 Williamsburg, VA 23185 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-25 |
| Decision Date | 2002-03-08 |