The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture.
| Device ID | K151165 |
| 510k Number | K151165 |
| Device Name: | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| 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 | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2016-02-17 |
| Summary: | summary |