The following data is part of a premarket notification filed by Reprobitech Corp. with the FDA for Ivitri Straw.
| Device ID | K172751 |
| 510k Number | K172751 |
| Device Name: | IVitri Straw |
| Classification | Labware, Assisted Reproduction |
| Applicant | Reprobitech Corp. 42-31 Colden St., Suite 202 Flushing, NY 11355 |
| Contact | Huai L. Feng |
| Correspondent | Huai L. Feng Reprobitech Corp. 42-31 Colden St., Suite 202 Flushing, NY 11355 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-12 |
| Decision Date | 2018-02-09 |
| Summary: | summary |