The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Coated Vicryl Plus Antimicrobial (polyglactin 910) Synthetic Absorbable Suture.
| Device ID | K132580 |
| 510k Number | K132580 |
| Device Name: | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Peter Cecchini |
| Correspondent | Peter Cecchini 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 | 2013-08-16 |
| Decision Date | 2014-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031236848 | K132580 | 000 |
| 30705031056590 | K132580 | 000 |
| 30705031056538 | K132580 | 000 |
| 30705031056446 | K132580 | 000 |
| 30705031056385 | K132580 | 000 |