The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Fastens(tm).
| Device ID | K854316 |
| 510k Number | K854316 |
| Device Name: | FASTENS(TM) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Contact | Bruce Macfarlane |
| Correspondent | Bruce Macfarlane MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1986-02-28 |