The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Vicryl Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, Pds Ii Polydioxanone Sterile Synthetic Absorbable Surgical Suture, Pds Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture.
| Device ID | K183183 |
| 510k Number | K183183 |
| Device Name: | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, NJ 08876 |
| Contact | Stephanie Saati |
| Correspondent | Stephanie Saati Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, NJ 08876 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-11-19 |
| Decision Date | 2019-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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