The following data is part of a premarket notification filed by Control Solutions, Inc. with the FDA for Control Solutions Inc, Model Cs3101.
| Device ID | K993420 |
| 510k Number | K993420 |
| Device Name: | CONTROL SOLUTIONS INC, MODEL CS3101 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CONTROL SOLUTIONS, INC. 508 W. 5TH AVE. Naperville, IL 60563 |
| Contact | John Hayden |
| Correspondent | John Hayden CONTROL SOLUTIONS, INC. 508 W. 5TH AVE. Naperville, IL 60563 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-12 |
| Decision Date | 2000-07-19 |