Dermalex or Natrawool Skin Pressure Prot
FDA 510(k) K801195 · Stock Wild & Co.
510(k) numberK801195
Submission
- Device name
- Dermalex or Natrawool Skin Pressure Prot
- Applicant
- Stock Wild & Co.
Mchenry, IL, US - Received
- May 16, 1980
- Decision date
- June 9, 1980
- 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 |
| K811184 | Spenco Dermal PadsFMP · Traditional | Spenco Medical Corp. | 05/20/1981SE |
| 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 |
| K792297 | Span Aids KitFMP · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
Questions and answers
When was Dermalex or Natrawool Skin Pressure Prot cleared by the FDA?
Dermalex or Natrawool Skin Pressure Prot (K801195) received a 510(k) decision of Substantially Equivalent on June 9, 1980, 24 days after the submission was received.
What is the product code of K801195?
The FDA product code is FMP – Protector, Skin Pressure, a Class I (low risk) device regulated under 21 CFR 880.6450.