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 | K172050 |
| 510k Number | K172050 |
| Device Name: | Follicle Aspiration Set, Reduced Single Lumen |
| Classification | Needle, Assisted Reproduction |
| Applicant | Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda, SE Se-42132 |
| Contact | Anja Bengtzelius |
| Correspondent | Greg Holland Regulatory Specialist, Inc. 3722 Ave. Sausalito Irvine, CA 92606 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-06 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025915460 | K172050 | 000 |
| 17350025915453 | K172050 | 000 |
| 17350025915446 | K172050 | 000 |
| 17350025915439 | K172050 | 000 |