The following data is part of a premarket notification filed by Vitromed Langenfeld with the FDA for V-hepes Plus.
| Device ID | K213293 |
| 510k Number | K213293 |
| Device Name: | V-HEPES PLUS |
| Classification | Media, Reproductive |
| Applicant | Vitromed Langenfeld Raoffeosemstr 15a Langenfeld, DE 40764 |
| Contact | Greg Holland |
| Correspondent | Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-09-14 |