The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Hepatostat Set, Model 760x.
| Device ID | K061796 |
| 510k Number | K061796 |
| Device Name: | HEPATOSTAT SET, MODEL 760X |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | VYGON CORP. 30833 NORTHWESTERS HWY SUITE 121 Farmington Hills, MI 48334 |
| Contact | Stephen Goldner |
| Correspondent | Stephen Goldner VYGON CORP. 30833 NORTHWESTERS HWY SUITE 121 Farmington Hills, MI 48334 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-11-02 |
| Summary: | summary |