The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Thopaz+.
| Device ID | K141553 |
| 510k Number | K141553 |
| Device Name: | MEDELA THOPAZ+ |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 7B Baar, Zug, CH 6341 |
| Contact | Orlando Antunes |
| Correspondent | Orlando Antunes MEDELA AG LAETTICHSTRASSE 7B Baar, Zug, CH 6341 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-11 |
| Decision Date | 2014-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367043304 | K141553 | 000 |
| 07612367014120 | K141553 | 000 |
| 07612367038676 | K141553 | 000 |
| 07612367038652 | K141553 | 000 |
| 07612367024761 | K141553 | 000 |
| 07612367078122 | K141553 | 000 |
| 07612367078108 | K141553 | 000 |
| 07612367038904 | K141553 | 000 |
| 07612367038713 | K141553 | 000 |
| 07612367038669 | K141553 | 000 |
| 07612367038522 | K141553 | 000 |
| 07612367043298 | K141553 | 000 |
| 07612367042703 | K141553 | 000 |
| 07612367042680 | K141553 | 000 |
| 07612367041027 | K141553 | 000 |
| 07612367038706 | K141553 | 000 |
| 07612367038690 | K141553 | 000 |
| 07612367038539 | K141553 | 000 |
| 07612367038683 | K141553 | 000 |
| 07612367025133 | K141553 | 000 |