The following data is part of a premarket notification filed by Custom Ultrasonics with the FDA for System 83 Plus Miniflex Washer-disinfector.
| Device ID | K061430 |
| 510k Number | K061430 |
| Device Name: | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | CUSTOM ULTRASONICS 144 RAILROAD DR. Ivyland, PA 18974 |
| Contact | Lawrence F Muscarella |
| Correspondent | Lawrence F Muscarella CUSTOM ULTRASONICS 144 RAILROAD DR. 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 | 2006-05-23 |
| Decision Date | 2007-01-12 |
| Summary: | summary |