The following data is part of a premarket notification filed by Aslan Medical Technologies, Ltd. with the FDA for Aslan Dual Action Jaws Grasping Forceps.
| Device ID | K944082 |
| 510k Number | K944082 |
| Device Name: | ASLAN DUAL ACTION JAWS GRASPING FORCEPS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. Kalamazoo, MI 49009 |
| Contact | Dr. Thomas J Hoogeboom |
| Correspondent | Dr. Thomas J Hoogeboom ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. Kalamazoo, MI 49009 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-22 |
| Decision Date | 1994-09-13 |