The following data is part of a premarket notification filed by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. with the FDA for Sterilization Wraps.
| Device ID | K220133 |
| 510k Number | K220133 |
| Device Name: | Sterilization Wraps |
| Classification | Wrap, Sterilization |
| Applicant | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. No.567, Gushan Road, Area Of Economy And Technique Weihai, CN 264207 |
| Contact | Bin Dong |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No. 5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0311430501 | K220133 | 000 |
| B0311418500 | K220133 | 000 |