The following data is part of a premarket notification filed by Hu-friedy Mfg. Co.,inc. with the FDA for Symmetry S-series Piezoelectric Scaling Tips.
| Device ID | K053178 |
| 510k Number | K053178 |
| Device Name: | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS |
| Classification | Scaler, Ultrasonic |
| Applicant | HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. Chicago, IL 60618 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. 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 | 2005-11-14 |
| Decision Date | 2006-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950076108 | K053178 | 000 |
| 10889950075934 | K053178 | 000 |
| 10889950075927 | K053178 | 000 |
| 10889950075910 | K053178 | 000 |
| 10889950075224 | K053178 | 000 |
| 10889950075187 | K053178 | 000 |
| 10889950075170 | K053178 | 000 |
| 10889950075163 | K053178 | 000 |
| 10889950075156 | K053178 | 000 |
| 10889950075149 | K053178 | 000 |
| 10889950075132 | K053178 | 000 |
| 10889950075941 | K053178 | 000 |
| 10889950075958 | K053178 | 000 |
| 10889950076092 | K053178 | 000 |
| 10889950076047 | K053178 | 000 |
| 10889950076030 | K053178 | 000 |
| 10889950076023 | K053178 | 000 |
| 10889950076016 | K053178 | 000 |
| 10889950076009 | K053178 | 000 |
| 10889950075996 | K053178 | 000 |
| 10889950075989 | K053178 | 000 |
| 10889950075972 | K053178 | 000 |
| 10889950075965 | K053178 | 000 |
| 10889950075125 | K053178 | 000 |