The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Follicle Aspiration Set, Reduced Single Lumen.
| Device ID | K082727 |
| 510k Number | K082727 |
| Device Name: | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN |
| Classification | Needle, Assisted Reproduction |
| Applicant | VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka, SE Se-434 37 |
| Contact | Kjell Kjork |
| Correspondent | Kjell Kjork VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka, SE Se-434 37 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-17 |
| Decision Date | 2009-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025914753 | K082727 | 000 |
| 17350025914746 | K082727 | 000 |
| 17350025914296 | K082727 | 000 |
| 07350025914282 | K082727 | 000 |
| 17350025914272 | K082727 | 000 |
| 17350025914234 | K082727 | 000 |