The following data is part of a premarket notification filed by Kitazato Biopharma Co., Ltd. with the FDA for Cryotop Vitrification Kit And Cryotop Thawing Kit.
| Device ID | K160864 |
| 510k Number | K160864 |
| Device Name: | Cryotop Vitrification Kit And Cryotop Thawing Kit |
| Classification | Media, Reproductive |
| Applicant | KITAZATO BIOPHARMA CO., LTD. 81 NAKIJIMA Fuji, JP 416-0907 |
| Contact | Futoshi Inoue |
| Correspondent | Richard Vincins EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-03-29 |
| Decision Date | 2016-10-07 |
| Summary: | summary |