Med-Tec Testicular Separator
FDA 510(k) K951679 · Medtec, Inc.
510(k) numberK951679
Submission
- Device name
- Med-Tec Testicular Separator
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- April 11, 1995
- Decision date
- July 12, 1995
- 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 Testicular Separator cleared by the FDA?
Med-Tec Testicular Separator (K951679) received a 510(k) decision of Substantially Equivalent on July 12, 1995, 92 days after the submission was received.
What is the product code of K951679?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.