The following data is part of a premarket notification filed by Changzhou Rongxin Medicine Minimal Invasion Technology with the FDA for Silicone Foley Catheter For Single Use.
Device ID | K172807 |
510k Number | K172807 |
Device Name: | Silicone Foley Catheter For Single Use |
Classification | Catheter, Retention Type, Balloon |
Applicant | Changzhou Rongxin Medicine Minimal Invasion Technology No. 8, Jianerkang Road, Industrial Concentration Area, Zhixi Town Jintan City, CN 213251 |
Contact | Ping Liu |
Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9Th Floor, R&D Building, No. 26 Qinglan Street Panyu District Guangzhou, CN 510006 |
Product Code | EZL |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-18 |
Decision Date | 2018-06-04 |
Summary: | summary |