The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Coated Vicryl* (polyglactin 910) Suture.
| Device ID | K022269 |
| 510k Number | K022269 |
| Device Name: | COATED VICRYL* (POLYGLACTIN 910) SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Lea Ann Conway |
| Correspondent | Lea Ann Conway ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-09-13 |
| Summary: | summary |