The following data is part of a premarket notification filed by U&u Medical Technology Co., Ltd with the FDA for U&u Hydrogen Peroxide Gas Plasma Sterilization Pouch/roll.
| Device ID | K123162 |
| 510k Number | K123162 |
| Device Name: | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888277690053 | K123162 | 000 |
| 30888277690077 | K123162 | 000 |
| 50732224009051 | K123162 | 000 |
| 50732224009037 | K123162 | 000 |
| 50732224009013 | K123162 | 000 |
| 50732224009006 | K123162 | 000 |