The following data is part of a premarket notification filed by U&u Medical Technology Co., Ltd with the FDA for U&u Bowie-dick Test Pack.
| Device ID | K143629 |
| 510k Number | K143629 |
| Device Name: | U&U Bowie-Dick Test Pack |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, CN 213119 |
| Contact | Garfield Wang |
| Correspondent | Garfield Wang U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, CN 213119 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-05-19 |
| Summary: | summary |