The following data is part of a premarket notification filed by Serral, S.a. De C.v. with the FDA for Serralgut.
| Device ID | K020597 |
| 510k Number | K020597 |
| Device Name: | SERRALGUT |
| Classification | Suture, Absorbable, Natural |
| 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 | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-22 |
| Decision Date | 2002-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780363866 | K020597 | 000 |
| H834625001 | K020597 | 000 |
| H834625021 | K020597 | 000 |
| H834625031 | K020597 | 000 |
| H834625041 | K020597 | 000 |
| H834625051 | K020597 | 000 |
| H834625061 | K020597 | 000 |
| H834625071 | K020597 | 000 |
| 10381780363798 | K020597 | 000 |
| 10381780363804 | K020597 | 000 |
| 10381780363811 | K020597 | 000 |
| 10381780363828 | K020597 | 000 |
| 10381780363835 | K020597 | 000 |
| 10381780363842 | K020597 | 000 |
| 10381780363859 | K020597 | 000 |
| H834625011 | K020597 | 000 |