The following data is part of a premarket notification filed by Medpro Safety Products, Inc. with the FDA for Vacuette Premium Safety Needle System.
| Device ID | K072602 |
| 510k Number | K072602 |
| Device Name: | VACUETTE PREMIUM SAFETY NEEDLE SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDPRO SAFETY PRODUCTS, INC. 250 WEST MAIN STREET SUITE 2700 Lexington, KY 40507 -1749 |
| Contact | Greg E Mitchell |
| Correspondent | Greg E Mitchell MEDPRO SAFETY PRODUCTS, INC. 250 WEST MAIN STREET SUITE 2700 Lexington, KY 40507 -1749 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2008-06-18 |
| Summary: | summary |