The following data is part of a premarket notification filed by Custom Ultrasonics with the FDA for Modification To System 83 Plus.
| Device ID | K983017 |
| 510k Number | K983017 |
| Device Name: | MODIFICATION TO SYSTEM 83 PLUS |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | CUSTOM ULTRASONICS 144 RAILROAD DR. Ivyland, PA 18974 |
| Contact | Frank J Weber |
| Correspondent | Frank J Weber CUSTOM ULTRASONICS 144 RAILROAD DR. Ivyland, PA 18974 |
| Product Code | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333241330 | K983017 | 000 |
| 04961333241323 | K983017 | 000 |
| 04961333241316 | K983017 | 000 |
| 04961333241309 | K983017 | 000 |
| 04961333241293 | K983017 | 000 |
| 04961333241286 | K983017 | 000 |