The following data is part of a premarket notification filed by Becton Dickinson Labware with the FDA for Falcon Ivf One Well Dish.
| Device ID | K991251 |
| 510k Number | K991251 |
| Device Name: | FALCON IVF ONE WELL DISH |
| Classification | Labware, Assisted Reproduction |
| Applicant | BECTON DICKINSON LABWARE 1 BECTON DR. Franklin Lakes, NJ 07465 -1886 |
| Contact | David Ball |
| Correspondent | David Ball BECTON DICKINSON LABWARE 1 BECTON DR. Franklin Lakes, NJ 07465 -1886 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-13 |
| Decision Date | 1999-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50389151000011 | K991251 | 000 |