The following data is part of a premarket notification filed by Mdk (shanghai) Medical Packing Co., Ltd. with the FDA for Paper Sterilization Pouch And Roll(sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat And Sterilization Roll Gusseted).
| Device ID | K182184 |
| 510k Number | K182184 |
| Device Name: | Paper Sterilization Pouch And Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat And Sterilization Roll Gusseted) |
| Classification | Wrap, Sterilization |
| Applicant | MDK (ShangHai) Medical Packing Co., Ltd. No. 233 Fengijan Rd, FengCheng Town, FengXian District Shanghai, CN 201409 |
| Contact | Gong Yaoren |
| Correspondent | Ray Wang MDK (ShangHai) Medical Packing Co., Ltd. No. 233 Fengijan Rd, FengCheng Town, FengXian District Shanghai, CN 201409 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2019-10-10 |
| Summary: | summary |