The following data is part of a premarket notification filed by Uzinmedicare Co. with the FDA for Spectra Cashmere.
| Device ID | K191208 |
| 510k Number | K191208 |
| Device Name: | Spectra Cashmere |
| Classification | Pump, Breast, Powered |
| Applicant | Uzinmedicare Co. 56, Dongtansandan 5-Gil, Dongtan-Myeon Hwaseong-si, KR 18487 |
| Contact | Nathan Ahn |
| Correspondent | Adrienne R. Lenz Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street, N.W. Suite 1200 Washington, DC 20005 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809108011364 | K191208 | 000 |
| 28809108016458 | K191208 | 000 |