The following data is part of a premarket notification filed by Hu-friedy Mfg. Co. Llc with the FDA for Hu-friedy Dental Cartridge Syringe.
| Device ID | K120659 |
| 510k Number | K120659 |
| Device Name: | HU-FRIEDY DENTAL CARTRIDGE SYRINGE |
| Classification | Syringe, Cartridge |
| Applicant | HU-FRIEDY MFG. CO. LLC 3232 N ROCKWELL STREET Chicago, IL 60618 |
| Contact | Maria Vrabie |
| Correspondent | Maria Vrabie HU-FRIEDY MFG. CO. LLC 3232 N ROCKWELL STREET Chicago, IL 60618 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-05 |
| Decision Date | 2012-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021333 | K120659 | 000 |
| 00816519021326 | K120659 | 000 |
| 00816519021319 | K120659 | 000 |
| 00842517100008 | K120659 | 000 |