Foramatron V, Model D680
FDA 510(k) K002195 · Parkell, Inc.
510(k) numberK002195
Submission
- Device name
- Foramatron V, Model D680
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- July 20, 2000
- Decision date
- August 30, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LQY – Locator, Root Apex
- Device class
- Unclassified
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Questions and answers
When was Foramatron V, Model D680 cleared by the FDA?
Foramatron V, Model D680 (K002195) received a 510(k) decision of Substantially Equivalent on August 30, 2000, 41 days after the submission was received.
What is the product code of K002195?
The FDA product code is LQY – Locator, Root Apex, a Unclassified device.