The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan Sternum Needle-suture.
| Device ID | K801976 |
| 510k Number | K801976 |
| Device Name: | SCANLAN STERNUM NEEDLE-SUTURE |
| Classification | Needle, Suturing, Disposable |
| Applicant | SCANLAN INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAB |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-09-26 |