The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Thopaz.
| Device ID | K130210 |
| 510k Number | K130210 |
| Device Name: | MEDELA THOPAZ |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Markus Buetler |
| Correspondent | Markus Buetler 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 | 2013-01-29 |
| Decision Date | 2013-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367038560 | K130210 | 000 |
| 07612367017497 | K130210 | 000 |
| 07612367017480 | K130210 | 000 |
| 07612367014205 | K130210 | 000 |