The following data is part of a premarket notification filed by Serral, S.a. De C.v. with the FDA for Serralapg.
| Device ID | K033762 |
| 510k Number | K033762 |
| Device Name: | SERRALAPG |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-02 |
| Decision Date | 2004-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780363927 | K033762 | 000 |
| 10381780363910 | K033762 | 000 |
| 10381780363903 | K033762 | 000 |
| H834625111 | K033762 | 000 |
| H834625131 | K033762 | 000 |
| H834625121 | K033762 | 000 |