Worldwide Medical Technologies Needle Guide
FDA 510(k) K981470 · Worldwide Medical Technologies, LLC
510(k) numberK981470
Submission
- Device name
- Worldwide Medical Technologies Needle Guide
- Applicant
- Worldwide Medical Technologies, LLC
Woodbury, CT, US - Received
- April 23, 1998
- Decision date
- June 19, 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 Worldwide Medical Technologies Needle Guide cleared by the FDA?
Worldwide Medical Technologies Needle Guide (K981470) received a 510(k) decision of Substantially Equivalent on June 19, 1998, 57 days after the submission was received.
What is the product code of K981470?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.