Nuclear Associates Glassers
FDA 510(k) K934362 · Victoreen, Inc.
510(k) numberK934362
Submission
- Device name
- Nuclear Associates Glassers
- Applicant
- Victoreen, Inc.
Solon, OH, US - Received
- September 8, 1993
- Decision date
- November 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K945515 | Coated Tungsten EyeshieldIWS · Traditional | Medtec, Inc. | 06/19/1995SE |
| K940119 | Royal Marsden Gold Grain GunIWS · Traditional | Best Industries | 12/30/1994SE |
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| K934459 | Med-Genesis Patient Laser Eye ShieldIWS · Traditional | Med-Genesis, Inc. | 02/22/1994SE |
| K920540 | Radiological Protective Eye ShieldIWS · Traditional | Burkhart Roentgen Intl., Inc. | 05/28/1992SE |
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Questions and answers
When was Nuclear Associates Glassers cleared by the FDA?
Nuclear Associates Glassers (K934362) received a 510(k) decision of Substantially Equivalent on November 12, 1993, 65 days after the submission was received.
What is the product code of K934362?
The FDA product code is IWS – Shield, Eye, Radiological, a Class I (low risk) device regulated under 21 CFR 892.6500.