The following data is part of a premarket notification filed by Thermo Fisher Scientific (nalge Nunc Intl) with the FDA for Nunc Ivf Centerwell And Icsi Dishes.
| Device ID | K090429 |
| 510k Number | K090429 |
| Device Name: | NUNC IVF CENTERWELL AND ICSI DISHES |
| Classification | Labware, Assisted Reproduction |
| Applicant | THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) 75 PANORAMA CREEK DRIVE Rochester, NY 14625 -2385 |
| Contact | Robert Prescott |
| Correspondent | Robert Prescott THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) 75 PANORAMA CREEK DRIVE Rochester, NY 14625 -2385 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866630000427 | K090429 | 000 |
| 00866630000434 | K090429 | 000 |
| H2861502655 | K090429 | 000 |
| H2861502605 | K090429 | 000 |