Med-Tec, Inc. Breast Board, MT-250
FDA 510(k) K935411 · Medtec, Inc.
510(k) numberK935411
Submission
- Device name
- Med-Tec, Inc. Breast Board, MT-250
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- November 9, 1993
- Decision date
- July 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Med-Tec, Inc. Breast Board, MT-250 cleared by the FDA?
Med-Tec, Inc. Breast Board, MT-250 (K935411) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 251 days after the submission was received.
What is the product code of K935411?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.