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 |