Micropower Hand Piece High Speed Drill
FDA 510(k) K060260 · Linvatec Corp.
510(k) numberK060260
Submission
- Device name
- Micropower Hand Piece High Speed Drill
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- February 1, 2006
- Decision date
- April 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Micropower Hand Piece High Speed Drill cleared by the FDA?
Micropower Hand Piece High Speed Drill (K060260) received a 510(k) decision of Substantially Equivalent on April 10, 2006, 68 days after the submission was received.
What is the product code of K060260?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.