The following data is part of a premarket notification filed by Medpro Safety Products, Inc. with the FDA for Vacuette Premium Safety Blood Collection Set.
| Device ID | K102010 |
| 510k Number | K102010 |
| Device Name: | VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDPRO SAFETY PRODUCTS, INC. 10 E. SCRANTON AVE SUITE 201 Lake Bluff, IL 60044 |
| Contact | H. Carl Jenkins |
| Correspondent | H. Carl Jenkins MEDPRO SAFETY PRODUCTS, INC. 10 E. SCRANTON AVE SUITE 201 Lake Bluff, IL 60044 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-16 |
| Decision Date | 2010-11-19 |
| Summary: | summary |