The following data is part of a premarket notification filed by Medtech Systems, Inc. with the FDA for Syringe Management System, Model Sms-1.
| Device ID | K001853 |
| 510k Number | K001853 |
| Device Name: | SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDTECH SYSTEMS, INC. 4825 OLSON MEMORIAL HIGHWAY, SUITE 103 Golden Valley, MN 55422 |
| Contact | Gary Miller |
| Correspondent | Gary Miller MEDTECH SYSTEMS, INC. 4825 OLSON MEMORIAL HIGHWAY, SUITE 103 Golden Valley, MN 55422 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-19 |
| Decision Date | 2001-08-22 |