CRYOTOP
Labware, Assisted Reproduction
KITAZATO BIOPHARMA CO;LTD
The following data is part of a premarket notification filed by Kitazato Biopharma Co;ltd with the FDA for Cryotop.
Pre-market Notification Details
| Device ID | K112695 |
| 510k Number | K112695 |
| Device Name: | CRYOTOP |
| Classification | Labware, Assisted Reproduction |
| Applicant | KITAZATO BIOPHARMA CO;LTD 611 WEST 5TH ST Austin, TX 78701 |
| Contact | Richard Vincins Cqa,rac(us,eu) |
| Correspondent | Richard Vincins Cqa,rac(us,eu) KITAZATO BIOPHARMA CO;LTD 611 WEST 5TH ST 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 | 2011-09-15 |
| Decision Date | 2012-12-12 |
| Summary: | summary |
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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