Spenco Dermal Pads
FDA 510(k) K811184 · Spenco Medical Corp.
510(k) numberK811184
Submission
- Device name
- Spenco Dermal Pads
- Applicant
- Spenco Medical Corp.
Mchenry, IL, US - Received
- April 29, 1981
- Decision date
- May 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMP – Protector, Skin Pressure
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6450
- Specialty
- General Hospital
Other 510(k)s with product code FMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150243 | Invictus Medical GelShieldFMP · Traditional | Invictus Medical, Inc. | 05/01/2015SE |
| K951325 | Comfeel Plus Pressure Relief DressingFMP · Traditional | Richard Hamer Assoc., Inc. | 07/31/1995SE |
| K934731 | Medsurg Sterile Imaging ProductsFMP · Traditional | Medsurg Industries, Inc. | 03/28/1994SE |
| K820584 | Decubicare Pads & AccessoriesFMP · Traditional | Abco Dealers, Inc. | 03/25/1982SE |
| K812344 | Heel or Elbow ProtectorFMP · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K802829 | Scanlan Vascu-StattFMP · Traditional | Scanlan Intl., Inc. | 01/15/1981SE |
| K802185 | Arterial Blood Sampling KitFMP · Traditional | Current Technologies, Inc. | 10/10/1980SE |
| K801694 | Flotation Pad for Operating TableFMP · Traditional | Action Products, Inc. | 08/27/1980SE |
| K801195 | Dermalex or Natrawool Skin Pressure ProtFMP · Traditional | Stock Wild & Co. | 06/09/1980SE |
| K792297 | Span Aids KitFMP · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
More from American Hospital Supply Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K981902 | Spenco Silicone Gel SheetMDA · Traditional | 06/25/1998SE |
| K922228 | 2ND Skin Sterile Adhesive StripKGX · Traditional | 12/11/1992SESK |
| K911550 | 2ND Skin Moist Burn Pads with AloeMGQ · Traditional | 09/06/1991SE |
| K910927 | Spencio Skin Guard KitKMF · Traditional | 06/03/1991SE |
| K896533 | Spenco Breast FormsKCZ · Traditional | 12/13/1989SE |
| K894898 | 2ND Skin Non-Stick Moist Burn PadsFRO · Traditional | 08/23/1989SE |
| K820906 | Spenco CryopressIMD · Traditional | 05/13/1982SE |
| K791726 | Hydrogel-PrepNAB · Traditional | 11/20/1979SE |
| K791162 | GelskinILO · Traditional | 09/04/1979SE |
Questions and answers
When was Spenco Dermal Pads cleared by the FDA?
Spenco Dermal Pads (K811184) received a 510(k) decision of Substantially Equivalent on May 20, 1981, 21 days after the submission was received.
What is the product code of K811184?
The FDA product code is FMP – Protector, Skin Pressure, a Class I (low risk) device regulated under 21 CFR 880.6450.