The following data is part of a premarket notification filed by Revolutions Medical Corporation Inc with the FDA for Revac Auto Retractable Safety Syringe.
| Device ID | K083193 |
| 510k Number | K083193 |
| Device Name: | REVAC AUTO RETRACTABLE SAFETY SYRINGE |
| Classification | Syringe, Piston |
| Applicant | REVOLUTIONS MEDICAL CORPORATION INC 670 Marina Drive 3rd Floor Charleston, SC 29492 |
| Contact | Richard Theriault |
| Correspondent | Richard Theriault REVOLUTIONS MEDICAL CORPORATION INC 670 Marina Drive 3rd Floor Charleston, SC 29492 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-29 |
| Decision Date | 2009-02-13 |
| Summary: | summary |