The following data is part of a premarket notification filed by Conod Medical Co., Limited with the FDA for Conod Enteral Feeding Sets.
| Device ID | K181276 |
| 510k Number | K181276 |
| Device Name: | CONOD Enteral Feeding Sets |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Conod Medical Co., Limited No.38 Hongfeng Road, Baimao Industrial Park Changshu, CN 310002 |
| Contact | Cheng Run |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 9th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, CN 510006 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-14 |
| Decision Date | 2018-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850005165283 | K181276 | 000 |
| 10850005165276 | K181276 | 000 |