The following data is part of a premarket notification filed by Shaoxing Fuqing Health Products Co., Ltd. with the FDA for Full Care Disposable Pvc Nelaton Catheter.
| Device ID | K151745 |
| 510k Number | K151745 |
| Device Name: | FULL CARE Disposable PVC Nelaton Catheter |
| Classification | Catheter, Straight |
| Applicant | SHAOXING FUQING HEALTH PRODUCTS CO., LTD. NO. 599 WUXIE ROAD, SHAOXING HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE Shaoxing, CN 312000 |
| Contact | Dean Wu |
| Correspondent | Mike Gu GUANGZHOU OSMUNDA MEDICAL DEVICE TECHNOLOGY SERVICE CO., LTD 7TH FLOOR, JINGUI BUSINESS BUILDING BAIYUM DISTRICT Guangzhou, CN 510420 |
| Product Code | EZD |
| Subsequent Product Code | FCM |
| Subsequent Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2016-03-03 |
| Summary: | summary |