The following data is part of a premarket notification filed by Kitazato Biopharma Co., Ltd. with the FDA for Cryotop(r) Sc.
| Device ID | K140072 |
| 510k Number | K140072 |
| Device Name: | CRYOTOP(R) SC |
| Classification | Labware, Assisted Reproduction |
| Applicant | KITAZATO BIOPHARMA CO., LTD. 816 CONGRESS AVE SUITE 1400 Austin, TX 78701 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins KITAZATO BIOPHARMA CO., LTD. 816 CONGRESS AVE 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 | 2014-01-13 |
| Decision Date | 2014-04-03 |
| Summary: | summary |