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 |