The following data is part of a premarket notification filed by Mitaka Usa, Inc. with the FDA for Mitaka Point Setter.
| Device ID | K991989 |
| 510k Number | K991989 |
| Device Name: | MITAKA POINT SETTER |
| Classification | Endoscope, Neurological |
| Applicant | MITAKA USA, INC. 2337 LUCKY JOHN DR. Park City, UT 84060 |
| Contact | Max Sturgis |
| Correspondent | Max Sturgis MITAKA USA, INC. 2337 LUCKY JOHN DR. Park City, UT 84060 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-14 |
| Decision Date | 1999-08-27 |
| Summary: | summary |