The following data is part of a premarket notification filed by Mdc Research Ltd. with the FDA for Safestep Safety Dental Cartridge Injector, Model 33-00000-1.
| Device ID | K022959 |
| 510k Number | K022959 |
| Device Name: | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 |
| Classification | Syringe, Cartridge |
| Applicant | MDC RESEARCH LTD. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson MDC RESEARCH LTD. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-06 |
| Decision Date | 2003-02-05 |
| Summary: | summary |