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 |