The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Steelex Sternum Set.
| Device ID | K023411 |
| 510k Number | K023411 |
| Device Name: | STEELEX STERNUM SET |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Georg Keller |
| Correspondent | Georg Keller AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-11 |
| Decision Date | 2002-12-19 |
| Summary: | summary |