The following data is part of a premarket notification filed by Wuxi Xinzhongrui Baby Supplies Co., Ltd. with the FDA for Megna Breast Pumps.
Device ID | K142479 |
510k Number | K142479 |
Device Name: | MEGNA BREAST PUMPS |
Classification | Pump, Breast, Powered |
Applicant | WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT Wuxi City, CN 214000 |
Contact | Anne Chen |
Correspondent | David Zeng MEGNA INC. 1043 ANDREW DRIVE West Chester, PA 19380 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-04 |
Decision Date | 2015-02-24 |