The following data is part of a premarket notification filed by Hertart with the FDA for Culture Dish 40 Mm, Culture Dish 60 Mm, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish.
| Device ID | K123641 |
| 510k Number | K123641 |
| Device Name: | CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH |
| Classification | Labware, Assisted Reproduction |
| Applicant | HERTART KORSKILDELUND 6 Greve, DK 2670 |
| Contact | Henrik Dorge |
| Correspondent | Henrik Dorge HERTART KORSKILDELUND 6 Greve, DK 2670 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-26 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27350025914538 | K123641 | 000 |
| 27350025914521 | K123641 | 000 |
| 27350025914514 | K123641 | 000 |
| 27350025914507 | K123641 | 000 |
| 27350025914491 | K123641 | 000 |
| 27350025914484 | K123641 | 000 |