The following data is part of a premarket notification filed by Hertart with the FDA for Micro Well Group Culture Dish, 9-well; Micro Well Group Culture Dish, 16-well.
| Device ID | K150756 |
| 510k Number | K150756 |
| Device Name: | Micro Well Group Culture Dish, 9-well; Micro Well Group Culture Dish, 16-well |
| Classification | Labware, Assisted Reproduction |
| Applicant | HERTART Gustaf Werners Gata 2 V. Frolunda, SE Se-421 32 |
| Contact | Michael Trinkle |
| Correspondent | Goran Mellbin HERTART APS Gustaf Werners Gata 2 Vastra Frolunda, SE 431 32 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712714666063 | K150756 | 000 |
| 05712714666049 | K150756 | 000 |
| 17350025919062 | K150756 | 000 |
| 17350025919048 | K150756 | 000 |