The following data is part of a premarket notification filed by U&u Medical Technology Co.,ltd with the FDA for U&u Sterilization Pouch And Roll.
Device ID | K143637 |
510k Number | K143637 |
Device Name: | U&U Sterilization Pouch And Roll |
Classification | Wrap, Sterilization |
Applicant | U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,jiangshu, CN 213119 |
Contact | Garfield Wang |
Correspondent | Garfield Wang U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,jiangshu, CN 213119 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-22 |
Decision Date | 2015-09-09 |
Summary: | summary |