Aarhus Anchorage System
FDA 510(k) K041527 · Medicon EG
510(k) numberK041527
Submission
- Device name
- Aarhus Anchorage System
- Applicant
- Medicon EG
Orange, CA, US - Received
- June 8, 2004
- Decision date
- August 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aarhus Anchorage System cleared by the FDA?
Aarhus Anchorage System (K041527) received a 510(k) decision of Substantially Equivalent on August 19, 2004, 72 days after the submission was received.
What is the product code of K041527?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.