The following data is part of a premarket notification filed by Kitazato Biopharma Co., Ltd. with the FDA for Pbs(-), Phosphate Buffered Saline.
| Device ID | K160863 |
| 510k Number | K160863 |
| Device Name: | PBS(-), Phosphate Buffered Saline |
| Classification | Media, Reproductive |
| Applicant | KITAZATO BIOPHARMA CO., LTD. 81 NAKIJIMA Fuji, JP 416-0907 |
| Contact | Futoshi Inoue |
| Correspondent | Diane Sudduth EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE, 1400 Austin, TX 78701 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573316381577 | K160863 | 000 |
| 04573316381560 | K160863 | 000 |