The following data is part of a premarket notification filed by U&u Medical Technology Co., Ltd with the FDA for U&u Sterile Hypodermic Needle.
Device ID | K132552 |
510k Number | K132552 |
Device Name: | U&U STERILE HYPODERMIC NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, Jiangsu, CN 213119 |
Contact | Xuebo Wang |
Correspondent | Xuebo Wang U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, Jiangsu, CN 213119 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-14 |
Decision Date | 2013-11-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
G002011070 | K132552 | 000 |