The following data is part of a premarket notification filed by Jiangsu Zhande Medical Supplies Co., Ltd with the FDA for Jambro Single Core A Sterilization Wrap.
| Device ID | K182656 |
| 510k Number | K182656 |
| Device Name: | JAMBRO Single Core A Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | Jiangsu Zhande Medical Supplies Co., Ltd Nanjing Binjiang Economic Development Park #719 Shengan Avenue, 1/F Build. Nanjing, CN 211178 |
| Contact | Chanjuan Xu |
| Correspondent | Jigar Shah mdi Consultants, Inc. 55 Northern Blvd Great Neck, NY 11021 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2019-06-11 |