The following data is part of a premarket notification filed by Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd with the FDA for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump.
| Device ID | K182749 |
| 510k Number | K182749 |
| Device Name: | Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd Sti. 10006 Sok. No: 64 AOSB Cigli, TR 35620 |
| Contact | Lindsay Ewers |
| Correspondent | Lindsay Ewers Lansinoh Laboratories 333 N Fairfax St Ste 400 Alexandria, VA 22314 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-06-12 |
| Summary: | summary |