The following data is part of a premarket notification filed by Ronvig Instruments, Ltd. with the FDA for Aspiject Self-aspirating Dental Injection Syringe.
| Device ID | K002168 |
| 510k Number | K002168 |
| Device Name: | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE |
| Classification | Syringe, Cartridge |
| Applicant | RONVIG INSTRUMENTS, LTD. GL.VEJLEVEJ 57-59 Dk-8721 Daugaard, DK Dk-8721 |
| Contact | Annette Ravn Neilsen |
| Correspondent | Annette Ravn Neilsen RONVIG INSTRUMENTS, LTD. GL.VEJLEVEJ 57-59 Dk-8721 Daugaard, DK Dk-8721 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00303620000017 | K002168 | 000 |
| 00303620000000 | K002168 | 000 |
| 05713513000010 | K002168 | 000 |