The following data is part of a premarket notification filed by Safe Secure Packing Co., Ltd. with the FDA for Safe Secure Sterilization Pouches And Rolls.
| Device ID | K180139 |
| 510k Number | K180139 |
| Device Name: | Safe Secure Sterilization Pouches And Rolls |
| Classification | Wrap, Sterilization |
| Applicant | Safe Secure Packing Co., Ltd. Yaoshan Industrial Park Xiegang Town Dongguan City, CN 523601 |
| Contact | Howard Jia |
| Correspondent | Howard Jia Safe Secure Packing Co., Ltd. Yaoshan Industrial Park Xiegang Town Dongguan City, CN 523601 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-18 |
| Decision Date | 2019-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885632243893 | K180139 | 000 |
| 30885632244081 | K180139 | 000 |
| 30885632244098 | K180139 | 000 |
| 30885632244104 | K180139 | 000 |
| 30885632244111 | K180139 | 000 |
| 20885632243902 | K180139 | 000 |
| 20885632243940 | K180139 | 000 |
| 30885632243848 | K180139 | 000 |
| 30885632243855 | K180139 | 000 |
| 30885632243862 | K180139 | 000 |
| 30885632243879 | K180139 | 000 |
| 20885632243933 | K180139 | 000 |