The following data is part of a premarket notification filed by Hu-friedy Mfg. Co.,inc. with the FDA for Modification To:hu-friedy Brand Satin Swivel Ultrasonic Insert.
| Device ID | K012060 |
| 510k Number | K012060 |
| Device Name: | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950075798 | K012060 | 000 |
| 10889950075484 | K012060 | 000 |
| 10889950075415 | K012060 | 000 |
| 10889950075408 | K012060 | 000 |
| 10889950075392 | K012060 | 000 |
| 10889950075385 | K012060 | 000 |
| 10889950075378 | K012060 | 000 |
| 10889950075361 | K012060 | 000 |
| 10889950121709 | K012060 | 000 |
| 10889950121693 | K012060 | 000 |
| 10889950124977 | K012060 | 000 |
| 10889950075491 | K012060 | 000 |
| 10889950075507 | K012060 | 000 |
| 10889950075781 | K012060 | 000 |
| 10889950075774 | K012060 | 000 |
| 10889950075767 | K012060 | 000 |
| 10889950075668 | K012060 | 000 |
| 10889950075651 | K012060 | 000 |
| 10889950075644 | K012060 | 000 |
| 10889950075637 | K012060 | 000 |
| 10889950075620 | K012060 | 000 |
| 10889950075613 | K012060 | 000 |
| 10889950075514 | K012060 | 000 |
| 10889950124960 | K012060 | 000 |