The following data is part of a premarket notification filed by Custom Ultrasonics Inc. with the FDA for Scope-assist Flushing Sink.
| Device ID | K162120 |
| 510k Number | K162120 |
| Device Name: | Scope-Assist Flushing Sink |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | Custom Ultrasonics Inc. 144 Railroad Drive Ivyland, PA 18974 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro Custom Ultrasonics Inc. 144 Railroad Drive Ivyland, PA 18974 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| FLUSHINGSINKMODELS8 | K162120 | 000 |
| FLUSHINGSINKMODELS6 | K162120 | 000 |
| PPS83S8 | K162120 | 000 |
| PPS83S6 | K162120 | 000 |
| G434FLUSHINGSINKMODELS8 | K162120 | 000 |
| G434FLUSHINGSINKMODELS6 | K162120 | 000 |
| 00860010835227 | K162120 | 000 |
| 00860010835210 | K162120 | 000 |