The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Hepatostat Set.
| Device ID | K073493 |
| 510k Number | K073493 |
| Device Name: | HEPATOSTAT SET |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-05-06 |
| Summary: | summary |