The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Coated Vicryl Plus Antibacterial (polyglactin 910) Absorable Suture.
| Device ID | K181652 |
| 510k Number | K181652 |
| Device Name: | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-06-22 |
| Decision Date | 2018-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031078080 | K181652 | 000 |