Sure-Point Midline Stepping and Stabilization System
FDA 510(k) K050724 · C.R. Bard, Inc.
510(k) numberK050724
Submission
- Device name
- Sure-Point Midline Stepping and Stabilization System
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- March 21, 2005
- Decision date
- April 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sure-Point Midline Stepping and Stabilization System cleared by the FDA?
Sure-Point Midline Stepping and Stabilization System (K050724) received a 510(k) decision of Substantially Equivalent on April 18, 2005, 28 days after the submission was received.
What is the product code of K050724?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.