The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Optilene Nonabsorbable Suture.
| Device ID | K180321 |
| 510k Number | K180321 |
| Device Name: | Aesculap Optilene Nonabsorbable Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A. Racosky |
| Correspondent | Kathy A. Racosky Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-05 |
| Decision Date | 2018-03-07 |
| Summary: | summary |