The following data is part of a premarket notification filed by Medela Ag with the FDA for Basic, Dominant Flex, Kv-6.
| Device ID | K150134 |
| 510k Number | K150134 |
| Device Name: | Basic, Dominant Flex, KV-6 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LATTICHSTRASSE 4B Baar, CH 6341 |
| Contact | Orlando Antunes |
| Correspondent | Adrienne Lenz PATHWAY REGULATORY CONSULTING, LLC W324 S3649 COUNTY ROAD E Dousman, WI 53118 |
| Product Code | BTA |
| Subsequent Product Code | HDB |
| Subsequent Product Code | MUU |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-21 |
| Decision Date | 2015-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367007061 | K150134 | 000 |
| 07612367045032 | K150134 | 000 |
| 07612367045018 | K150134 | 000 |
| 07612367052467 | K150134 | 000 |
| 07612367044974 | K150134 | 000 |
| 07612367045308 | K150134 | 000 |
| 07612367045292 | K150134 | 000 |
| 07612367006514 | K150134 | 000 |