The following data is part of a premarket notification filed by Aslan Medical Technologies, Ltd. with the FDA for Aslan Knot Pusher.
| Device ID | K950924 |
| 510k Number | K950924 |
| Device Name: | ASLAN KNOT PUSHER |
| Classification | Laparoscopy Kit |
| Applicant | ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. Kalamazoo, MI 49009 |
| Contact | Thomas J Hoogeboom |
| Correspondent | Thomas J Hoogeboom ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. Kalamazoo, MI 49009 |
| Product Code | FDE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-01 |
| Decision Date | 1995-03-14 |