The following data is part of a premarket notification filed by Samyang Corp. with the FDA for Surgisorb.
| Device ID | K984374 |
| 510k Number | K984374 |
| Device Name: | SURGISORB |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SAMYANG CORP. 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf SAMYANG CORP. 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1999-06-04 |
| Summary: | summary |