The following data is part of a premarket notification filed by Medical Design & Manufacturing Corp. with the FDA for Soft-ez Reusable Self-adhering Pigtail Electrodes.
| Device ID | K895604 |
| 510k Number | K895604 |
| Device Name: | SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | MEDICAL DESIGN & MANUFACTURING CORP. 929 EASTWIND DR. Westerville, OH 43081 |
| Contact | Michael Southworth |
| Correspondent | Michael Southworth MEDICAL DESIGN & MANUFACTURING CORP. 929 EASTWIND DR. Westerville, OH 43081 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1989-10-13 |