The following data is part of a premarket notification filed by Swemed Lab International Ab with the FDA for Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set.
| Device ID | K053208 |
| 510k Number | K053208 |
| Device Name: | CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET |
| Classification | Catheter, Assisted Reproduction |
| Applicant | SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2 Billdal, SE Se-427 36 |
| Contact | Anders Johansson |
| Correspondent | Anders Johansson SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2 Billdal, SE Se-427 36 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2006-01-30 |
| Summary: | summary |