The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Optilene Nonabsorbable Suture.
| Device ID | K133890 |
| 510k Number | K133890 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-07-15 |
| Summary: | summary |