The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Thopaz, Model 200 0288.
| Device ID | K080212 |
| 510k Number | K080212 |
| Device Name: | MEDELA THOPAZ, MODEL 200 0288 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Bruno Gretler |
| Correspondent | Bruno Gretler 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 | 2008-01-29 |
| Decision Date | 2008-07-23 |
| Summary: | summary |