Needle Guide
FDA 510(k) K983621 · Remington Medical, Inc.
510(k) numberK983621
Submission
- Device name
- Needle Guide
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- October 15, 1998
- Decision date
- November 3, 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 Needle Guide cleared by the FDA?
Needle Guide (K983621) received a 510(k) decision of Substantially Equivalent on November 3, 1998, 19 days after the submission was received.
What is the product code of K983621?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.