The following data is part of a premarket notification filed by Vitrolife, Inc. with the FDA for G-tl.
| Device ID | K133568 |
| 510k Number | K133568 |
| Device Name: | G-TL |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE, INC. 3601 SOUTH INCA ST. Englewood, CO 80110 |
| Contact | Mark Larman |
| Correspondent | Mark Larman VITROLIFE, INC. 3601 SOUTH INCA ST. Englewood, CO 80110 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-20 |
| Decision Date | 2014-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025910437 | K133568 | 000 |