The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan Single-use Aorta Punch.
| Device ID | K823764 |
| 510k Number | K823764 |
| Device Name: | SCANLAN SINGLE-USE AORTA PUNCH |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | SCANLAN INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-03-24 |