The following data is part of a premarket notification filed by Wuxi Xinzhongrui Baby Supplies Co.,ltd with the FDA for Electric Double Breast Pumps.
| Device ID | K151284 |
| 510k Number | K151284 |
| Device Name: | Electric Double Breast Pumps |
| Classification | Pump, Breast, Powered |
| Applicant | Wuxi Xinzhongrui Baby Supplies Co.,Ltd NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT Wuxi, CN 214115 |
| Contact | Shaozhong Chen |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, CN 200120 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-14 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867494000424 | K151284 | 000 |
| B311PEBRPUMP1 | K151284 | 000 |
| 00867494000417 | K151284 | 000 |
| 00842084000343 | K151284 | 000 |