Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185
FDA 510(k) K032607 · Linvatec Corp.
510(k) numberK032607
Submission
- Device name
- Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- August 25, 2003
- Decision date
- November 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 cleared by the FDA?
Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 (K032607) received a 510(k) decision of Substantially Equivalent on November 10, 2003, 77 days after the submission was received.
What is the product code of K032607?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.