The following data is part of a premarket notification filed by Hu-friedy Mfg. Co., Inc with the FDA for Swerv Magnetostrictive Ultrasonic Scaler System.
| Device ID | K100401 |
| 510k Number | K100401 |
| Device Name: | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET Chicago, IL 60618 |
| Contact | Maria Vrabie |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950075903 | K100401 | 000 |
| 10889950075828 | K100401 | 000 |
| 10889950075835 | K100401 | 000 |
| 10889950075842 | K100401 | 000 |
| 10889950075859 | K100401 | 000 |
| 10889950075866 | K100401 | 000 |
| 10889950075873 | K100401 | 000 |
| 10889950075880 | K100401 | 000 |
| 10889950075897 | K100401 | 000 |
| 10889950075118 | K100401 | 000 |