The following data is part of a premarket notification filed by Ronvig Instruments, Ltd. with the FDA for Paroject Anesthetic Syringe.
| Device ID | K904279 |
| 510k Number | K904279 |
| Device Name: | PAROJECT ANESTHETIC SYRINGE |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | RONVIG INSTRUMENTS, LTD. 18 LEXINGTON DR. Milford, DE 19963 |
| Contact | Daniel Parrilli |
| Correspondent | Daniel Parrilli RONVIG INSTRUMENTS, LTD. 18 LEXINGTON DR. Milford, DE 19963 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-17 |
| Decision Date | 1990-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00303620000031 | K904279 | 000 |
| 00303620000024 | K904279 | 000 |
| 05713513000058 | K904279 | 000 |