The following data is part of a premarket notification filed by Ningbo Feite Medical Device Co., Ltd with the FDA for Regular And Special Umbilical Cord Clamp And Cutter.
Device ID | K152350 |
510k Number | K152350 |
Device Name: | Regular And Special Umbilical Cord Clamp And Cutter |
Classification | Clamp And Cutter, Umbilical |
Applicant | NINGBO FEITE MEDICAL DEVICE CO., LTD TONGPENZHA, ZHONGGONGMIAO STREET, YINZHOU DISTRICT Ningbo, CN 315192 |
Contact | Charles Shen |
Correspondent | Charles Shen Manton Business And Technology Services 37 WINDING RIDGE Oakland, NJ 07436 |
Product Code | NBZ |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-20 |
Decision Date | 2016-06-28 |
Summary: | summary |