The following data is part of a premarket notification filed by U&u Medical Technology Co., Ltd with the FDA for U&u Indicator Tape And Strip.
| Device ID | K171823 |
| 510k Number | K171823 |
| Device Name: | U&U Indicator Tape And Strip |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | U&U Medical Technology Co., Ltd Dongzhou Village Hengshanqiao Changzhou, CN 213119 |
| Contact | Xuebo Wang |
| Correspondent | Xuebo 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 | 2017-06-19 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7966127 | K171823 | 000 |
| 10889950002398 | K171823 | 000 |
| 10889950002381 | K171823 | 000 |
| 10889950002374 | K171823 | 000 |
| 10889950002367 | K171823 | 000 |
| 10889950002343 | K171823 | 000 |
| 10889950002336 | K171823 | 000 |
| 10889950002329 | K171823 | 000 |
| 10889950002312 | K171823 | 000 |
| 10889950002305 | K171823 | 000 |
| 10889950002299 | K171823 | 000 |
| 10889950002268 | K171823 | 000 |
| 10889950002251 | K171823 | 000 |
| 10889950002213 | K171823 | 000 |
| 10889950002404 | K171823 | 000 |
| 10889950002411 | K171823 | 000 |
| D7966125 | K171823 | 000 |
| D79661250 | K171823 | 000 |
| D796612 | K171823 | 000 |
| D79661290 | K171823 | 000 |
| D79661270 | K171823 | 000 |
| D89260705600591 | K171823 | 000 |
| D89260705600581 | K171823 | 000 |
| D89260705600571 | K171823 | 000 |
| 10889950002466 | K171823 | 000 |
| 10889950002459 | K171823 | 000 |
| 10889950002442 | K171823 | 000 |
| 10889950002435 | K171823 | 000 |
| 10889950002428 | K171823 | 000 |
| 10889950002350 | K171823 | 000 |