The following data is part of a premarket notification filed by Lansinoh Laboratories Saglik Gerecleri Tasarim San with the FDA for Lansinoh Powered Electric Breast Pump.
| Device ID | K122474 |
| 510k Number | K122474 |
| Device Name: | LANSINOH POWERED ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN 13417 QUIVAS ST Westminster, CO 80234 |
| Contact | Calley Herzog |
| Correspondent | Calley Herzog LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN 13417 QUIVAS ST Westminster, CO 80234 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-14 |
| Decision Date | 2012-12-28 |
| Summary: | summary |