The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for Spenco Dermal Pads.
| Device ID | K811184 |
| 510k Number | K811184 |
| Device Name: | SPENCO DERMAL PADS |
| Classification | Protector, Skin Pressure |
| Applicant | SPENCO MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMP |
| CFR Regulation Number | 880.6450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-29 |
| Decision Date | 1981-05-20 |