The following data is part of a premarket notification filed by Nunc A/s with the FDA for Nunc Ivf Multidish 4 Wells Nunclon.
| Device ID | K040717 |
| 510k Number | K040717 |
| Device Name: | NUNC IVF MULTIDISH 4 WELLS NUNCLON |
| Classification | Labware, Assisted Reproduction |
| Applicant | NUNC A/S KAMSTRUPUEJ 90, KAMSTRUP Roskilde, DK Dk-4000 |
| Contact | Henrik Kvistgaard |
| Correspondent | Henrik Kvistgaard 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 | 2004-03-19 |
| Decision Date | 2004-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713311000014 | K040717 | 000 |