The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Gv 11 (tm), Model 9700.
| Device ID | K881082 |
| 510k Number | K881082 |
| Device Name: | GV 11 (TM), MODEL 9700 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Contact | Bruce Macfarlane,phd |
| Correspondent | Bruce Macfarlane,phd MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-03-28 |