Carbon Fiber Breast Board
FDA 510(k) K974703 · Medtec, Inc.
510(k) numberK974703
Submission
- Device name
- Carbon Fiber Breast Board
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- December 16, 1997
- Decision date
- March 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Carbon Fiber Breast Board cleared by the FDA?
Carbon Fiber Breast Board (K974703) received a 510(k) decision of Substantially Equivalent on March 10, 1998, 84 days after the submission was received.
What is the product code of K974703?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.