The following data is part of a premarket notification filed by Kitazato Biopharma Co., Ltd. with the FDA for Cryotop Us.
| Device ID | K153027 |
| 510k Number | K153027 |
| Device Name: | Cryotop US |
| Classification | Labware, Assisted Reproduction |
| Applicant | KITAZATO BIOPHARMA CO., LTD. 81 Nakajima Fuji, JP 416-0907 |
| Contact | Futoshi Inoue |
| Correspondent | Richard Vincins EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-16 |
| Decision Date | 2016-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14582231462930 | K153027 | 000 |
| 14582231462923 | K153027 | 000 |
| 14582231462916 | K153027 | 000 |
| 14582231462909 | K153027 | 000 |
| 14582231462893 | K153027 | 000 |