The following data is part of a premarket notification filed by Medela Ag with the FDA for Vario 8/18/ci.
| Device ID | K153663 |
| 510k Number | K153663 |
| Device Name: | Vario 8/18/ci |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LATTICHSTRASSE 4B Baar, CH 6341 |
| Contact | Markus Butler |
| Correspondent | Adrienne Lenz PATHWAY REGULATORY CONSULTING, LLC 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 | 2015-12-21 |
| Decision Date | 2016-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367052443 | K153663 | 000 |
| 07612367016308 | K153663 | 000 |
| 07612367015387 | K153663 | 000 |
| 07612367016094 | K153663 | 000 |
| 07612367019118 | K153663 | 000 |
| 07612367022903 | K153663 | 000 |
| 07612367022910 | K153663 | 000 |
| 07612367023221 | K153663 | 000 |
| 07612367024419 | K153663 | 000 |
| 07612367016131 | K153663 | 000 |