The following data is part of a premarket notification filed by Custom Ultrasonics with the FDA for Custom Ultrasonics-sys 80, 81-24, 83-2.
| Device ID | K842754 |
| 510k Number | K842754 |
| Device Name: | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | CUSTOM ULTRASONICS P.O. BOX 850 Buckingham , PA 18912 - |
| Contact | Frank J Weber |
| Correspondent | Frank J Weber CUSTOM ULTRASONICS P.O. BOX 850 Buckingham , PA 18912 - |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-16 |
| Decision Date | 1984-11-28 |