Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various
FDA 510(k) K060671 · Wfr/Aquaplast Corp.
510(k) numberK060671
Submission
- Device name
- Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various
- Applicant
- Wfr/Aquaplast Corp.
Wyckoff, NJ, US - Received
- March 14, 2006
- Decision date
- May 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various cleared by the FDA?
Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various (K060671) received a 510(k) decision of Substantially Equivalent on May 4, 2006, 51 days after the submission was received.
What is the product code of K060671?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.