The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Basic 30 And Dominant 50 Suction Pumps, Models 037, 057.
| Device ID | K021368 |
| 510k Number | K021368 |
| Device Name: | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 4 Ch-6340 Baar, CH |
| Contact | Rerner Frei |
| Correspondent | Mark Job 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 | 2002-04-30 |
| Decision Date | 2002-05-15 |