The following data is part of a premarket notification filed by Serral, S.a. De C.v. with the FDA for Serralsilk.
| Device ID | K020901 |
| 510k Number | K020901 |
| Device Name: | SERRALSILK |
| Classification | Suture, Nonabsorbable, Silk |
| 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 | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-20 |
| Decision Date | 2002-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780363897 | K020901 | 000 |
| 10381780363880 | K020901 | 000 |
| 10381780363873 | K020901 | 000 |
| H834625101 | K020901 | 000 |
| H834625081 | K020901 | 000 |
| H834625091 | K020901 | 000 |