The following data is part of a premarket notification filed by Mitaka Kohki Co., Ltd. with the FDA for Mitaka Uniarm.
| Device ID | K090792 |
| 510k Number | K090792 |
| Device Name: | MITAKA UNIARM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MITAKA KOHKI CO., LTD. 2337 LUCKY JOHN DRIVE Park City, UT 84060 |
| Contact | Maxwell Sturgis |
| Correspondent | Maxwell Sturgis MITAKA KOHKI CO., LTD. 2337 LUCKY JOHN DRIVE Park City, UT 84060 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-24 |
| Decision Date | 2009-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04589698450411 | K090792 | 000 |
| 04589698450022 | K090792 | 000 |