The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Vitrification Kit And Thawing Kit.
| Device ID | K171748 |
| 510k Number | K171748 |
| Device Name: | Vitrification Kit And Thawing Kit |
| Classification | Media, Reproductive |
| Applicant | Kitazato Corporation 81 Nakajima Fuji, JP 416-0907 |
| Contact | Futoshi Inoue |
| Correspondent | Diane Sudduth 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 | 2017-06-13 |
| Decision Date | 2017-12-14 |
| Summary: | summary |