Protect IV Gard
FDA 510(k) K772060 · Omnicon Medical Corp.
510(k) numberK772060
Submission
- Device name
- Protect IV Gard
- Applicant
- Omnicon Medical Corp.
Mchenry, IL, US - Received
- October 31, 1977
- Decision date
- December 20, 1977
- 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 |
| K801195 | Dermalex or Natrawool Skin Pressure ProtFMP · Traditional | Stock Wild & Co. | 06/09/1980SE |
More from Stock Wild & Co.
| 510(k) | Device | Decision |
|---|---|---|
| K823872 | Emergency Tracheostomy KitEWC · Traditional | 01/21/1983SE |
| K820577 | Anesthesia Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K820576 | Mainflow Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K801804 | Anesthesia Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K801803 | Mainflow Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K770136 | Disposable Bacteria FilterCAH · Traditional | 02/14/1977SE |
| K770001 | Airway, Berman 40, 60, 80, 90, L00MM'SCAE · Traditional | 01/12/1977SE |
| K760819 | Conductive Anesthesia Breathing CircuitCAI · Traditional | 10/27/1976SE |
| K760149 | Conductive Anesthsia Breath. CircuitCAI · Traditional | 07/19/1976SE |
Questions and answers
When was Protect IV Gard cleared by the FDA?
Protect IV Gard (K772060) received a 510(k) decision of Substantially Equivalent on December 20, 1977, 50 days after the submission was received.
What is the product code of K772060?
The FDA product code is FMP – Protector, Skin Pressure, a Class I (low risk) device regulated under 21 CFR 880.6450.