The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Dominant 35 C/i Secretion And Surgical Aspirator.
| Device ID | K043544 |
| 510k Number | K043544 |
| Device Name: | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 7 Baar, Zug, CH 6341 |
| Contact | Werner Frei |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-23 |
| Decision Date | 2005-01-07 |
| Summary: | summary |