Coated Tungsten Eyeshield
FDA 510(k) K945515 · Medtec, Inc.
510(k) numberK945515
Submission
- Device name
- Coated Tungsten Eyeshield
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- November 9, 1994
- Decision date
- June 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940119 | Royal Marsden Gold Grain GunIWS · Traditional | Best Industries | 12/30/1994SE |
| K943011 | Tungsten EyeshieldIWS · Traditional | Medtec, Inc. | 12/23/1994SE |
| K934459 | Med-Genesis Patient Laser Eye ShieldIWS · Traditional | Med-Genesis, Inc. | 02/22/1994SE |
| K934362 | Nuclear Associates GlassersIWS · Traditional | Victoreen, Inc. | 11/12/1993SE |
| K920540 | Radiological Protective Eye ShieldIWS · Traditional | Burkhart Roentgen Intl., Inc. | 05/28/1992SE |
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| K974703 | Carbon Fiber Breast BoardIYE · Traditional | 03/10/1998SE |
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| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | 12/05/1997SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | 10/01/1996SE |
| K955236 | Green TEC-2100IWE · Traditional | 05/24/1996SE |
| K954705 | Acrysteel Blocking TrayIYE · Traditional | 01/05/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | 12/21/1995SE |
Questions and answers
When was Coated Tungsten Eyeshield cleared by the FDA?
Coated Tungsten Eyeshield (K945515) received a 510(k) decision of Substantially Equivalent on June 19, 1995, 222 days after the submission was received.
What is the product code of K945515?
The FDA product code is IWS – Shield, Eye, Radiological, a Class I (low risk) device regulated under 21 CFR 892.6500.