The following data is part of a premarket notification filed by Hu-friedy Mfg. Co., Inc with the FDA for Symmetry Iq, Model 2000 Series, 3000 Series.
| Device ID | K070975 |
| 510k Number | K070975 |
| Device Name: | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES |
| Classification | Scaler, Ultrasonic |
| Applicant | HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET Chicago, IL 60618 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET Chicago, IL 60618 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950002633 | K070975 | 000 |
| 10889950002619 | K070975 | 000 |
| 10889950002602 | K070975 | 000 |
| 10889950002596 | K070975 | 000 |
| 10889950002589 | K070975 | 000 |
| 10889950002497 | K070975 | 000 |