The following data is part of a premarket notification filed by Nunc A/s with the FDA for Nunc Ivf Dishes And Nunc Ivf 4-well Dish.
| Device ID | K070047 |
| 510k Number | K070047 |
| Device Name: | NUNC IVF DISHES AND NUNC IVF 4-WELL DISH |
| Classification | Labware, Assisted Reproduction |
| Applicant | NUNC A/S KAMSTRUPUEJ 90, KAMSTRUP Roskilde, DK Dk-4000 |
| Contact | Jana S Hellmann |
| Correspondent | Jana S Hellmann NUNC A/S KAMSTRUPUEJ 90, KAMSTRUP Roskilde, DK Dk-4000 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-04 |
| Decision Date | 2007-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713311000052 | K070047 | 000 |
| 05713311000045 | K070047 | 000 |
| 05713311000038 | K070047 | 000 |
| 05713311000021 | K070047 | 000 |
| 35713311000169 | K070047 | 000 |
| 35713311000152 | K070047 | 000 |
| 35713311000145 | K070047 | 000 |
| 35713311000138 | K070047 | 000 |
| 35713311000121 | K070047 | 000 |