The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Ultrahesive Ii Postop Electrode.
| Device ID | K862028 |
| 510k Number | K862028 |
| Device Name: | ULTRAHESIVE II POSTOP ELECTRODE |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-08-01 |