Cryotop®US-flash And Cryotop®US-scoop
Labware, Assisted Reproduction
Kitazato Corporation
The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Cryotop®us-flash And Cryotop®us-scoop.
Pre-market Notification Details
| Device ID | K181469 |
| 510k Number | K181469 |
| Device Name: | Cryotop®US-flash And Cryotop®US-scoop |
| Classification | Labware, Assisted Reproduction |
| 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 | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14582231462886 | K181469 | 000 |
| 14582231462800 | K181469 | 000 |
| 14582231462817 | K181469 | 000 |
| 14582231462824 | K181469 | 000 |
| 14582231462831 | K181469 | 000 |
| 14582231462848 | K181469 | 000 |
| 14582231462855 | K181469 | 000 |
| 14582231462862 | K181469 | 000 |
| 14582231462879 | K181469 | 000 |
| 14582231462794 | K181469 | 000 |
Trademark Results [Cryotop]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOTOP 86546909 4944163 Live/Registered |
Kitazato BioPharma Co., Ltd. 2015-02-26 |
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