The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical Suture.
| Device ID | K060528 |
| 510k Number | K060528 |
| Device Name: | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-28 |
| Decision Date | 2006-03-28 |
| Summary: | summary |