The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Sepasperm Washing Solution, Sepasperm Solution.
| Device ID | K190199 |
| 510k Number | K190199 |
| Device Name: | SepaSperm Washing Solution, SepaSperm Solution |
| Classification | Media, Reproductive |
| Applicant | Kitazato Corporation 81 Nakajima Fuji-shi, JP 416-0907 |
| Contact | Futoshi Inoue |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573316381317 | K190199 | 000 |
| 04573316381300 | K190199 | 000 |
| 04573316381294 | K190199 | 000 |
| 04573316381287 | K190199 | 000 |
| 04573316381270 | K190199 | 000 |
| 04573316381263 | K190199 | 000 |
| 04573316381256 | K190199 | 000 |
| 04573316381249 | K190199 | 000 |