The following data is part of a premarket notification filed by Medpro Safety Products, Inc. with the FDA for Vacuette Premium Safety Needle System Tube-touch.
| Device ID | K111424 |
| 510k Number | K111424 |
| Device Name: | VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDPRO SAFETY PRODUCTS, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith MEDPRO SAFETY PRODUCTS, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2011-07-29 |
| Summary: | summary |