The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Follicle Aspiration Set.
| Device ID | K161970 |
| 510k Number | K161970 |
| Device Name: | Follicle Aspiration Set |
| Classification | Needle, Assisted Reproduction |
| Applicant | VITROLIFE SWEDEN AB GUSTAF WERNERS GATA 2 Vastra Frolunda, SE Se-421 32 |
| Contact | Anja Bengtzelius |
| Correspondent | Greg Holland REGULATORY SPECIALISTS, 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 | 2016-07-18 |
| Decision Date | 2017-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025915514 | K161970 | 000 |
| 17350025915231 | K161970 | 000 |
| 17350025915224 | K161970 | 000 |
| 17350025915217 | K161970 | 000 |
| 17350025915200 | K161970 | 000 |
| 17350025915194 | K161970 | 000 |
| 17350025915187 | K161970 | 000 |
| 17350025915170 | K161970 | 000 |
| 17350025915163 | K161970 | 000 |
| 17350025915156 | K161970 | 000 |
| 17350025915149 | K161970 | 000 |
| 17350025915132 | K161970 | 000 |
| 17350025915125 | K161970 | 000 |
| 17350025915118 | K161970 | 000 |
| 17350025915101 | K161970 | 000 |
| 17350025915095 | K161970 | 000 |
| 17350025915088 | K161970 | 000 |
| 17350025915071 | K161970 | 000 |
| 17350025915248 | K161970 | 000 |
| 17350025915255 | K161970 | 000 |
| 17350025915507 | K161970 | 000 |
| 17350025915491 | K161970 | 000 |
| 17350025915415 | K161970 | 000 |
| 17350025915408 | K161970 | 000 |
| 17350025915392 | K161970 | 000 |
| 17350025915385 | K161970 | 000 |
| 17350025915378 | K161970 | 000 |
| 17350025915361 | K161970 | 000 |
| 17350025915354 | K161970 | 000 |
| 17350025915347 | K161970 | 000 |
| 17350025915330 | K161970 | 000 |
| 17350025915323 | K161970 | 000 |
| 17350025915316 | K161970 | 000 |
| 17350025915309 | K161970 | 000 |
| 17350025915293 | K161970 | 000 |
| 17350025915286 | K161970 | 000 |
| 17350025915262 | K161970 | 000 |
| 17350025915064 | K161970 | 000 |