The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Vario 8/18/ci Secretion & Surgical Aspirator.
| Device ID | K061205 |
| 510k Number | K061205 |
| Device Name: | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Werner Frei |
| Correspondent | Werner Frei MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-06-21 |
| Summary: | summary |