The following data is part of a premarket notification filed by Medela Ag with the FDA for Basic And Dominant Flex Suction Pumps.
| Device ID | K130123 |
| 510k Number | K130123 |
| Device Name: | BASIC AND DOMINANT FLEX SUCTION PUMPS |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG W324S3649 COUNTY ROAD E Dousman, WI 53118 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz MEDELA AG W324S3649 COUNTY ROAD E Dousman, WI 53118 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-17 |
| Decision Date | 2013-10-11 |
| Summary: | summary |