The following data is part of a premarket notification filed by Aslan Medical Technologies, Ltd. with the FDA for Aslan Sensor Modular Instrument.
| Device ID | K982287 |
| 510k Number | K982287 |
| Device Name: | ASLAN SENSOR MODULAR INSTRUMENT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ASLAN MEDICAL TECHNOLOGIES, LTD. 4110 SOUTH 9TH ST. Kalamazoo, MI 49009 -8120 |
| Contact | Thomas J Hoogeboom |
| Correspondent | Thomas J Hoogeboom ASLAN MEDICAL TECHNOLOGIES, LTD. 4110 SOUTH 9TH ST. Kalamazoo, MI 49009 -8120 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-30 |
| Decision Date | 1998-08-06 |
| Summary: | summary |