The following data is part of a premarket notification filed by Hangzhou Bever Medical Devices Co., Ltd. with the FDA for Male, Nelaton-tip Ready-to-use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-tip Tiemann Ready-to-use Hydrophilic Catheter; Ma.
| Device ID | K192468 |
| 510k Number | K192468 |
| Device Name: | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Ma |
| Classification | Catheter, Urethral |
| Applicant | Hangzhou Bever Medical Devices Co., Ltd. Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian St., Yuhang Dist. Hangzhou, CN 311121 |
| Contact | Allyson Zhou |
| Correspondent | Allyson Zhou Hangzhou Bever Medical Devices, Co., Ltd. Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian St., Yuhang Dist. Hangzhou, CN 311121 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16948796204060 | K192468 | 000 |
| 16948796203964 | K192468 | 000 |
| 16948796203971 | K192468 | 000 |
| 16948796203988 | K192468 | 000 |
| 16948796203995 | K192468 | 000 |
| 16948796204008 | K192468 | 000 |
| 16948796204015 | K192468 | 000 |
| 16948796204022 | K192468 | 000 |
| 16948796204039 | K192468 | 000 |
| 16948796204046 | K192468 | 000 |
| 16948796204053 | K192468 | 000 |
| 16948796203957 | K192468 | 000 |