Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring Ct/Mr Applicator Set,Model 110.330,
FDA 510(k) K091154 · Nucletron Corporation
510(k) numberK091154
Submission
- Device name
- Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring Ct/Mr Applicator Set,Model 110.330,
- Applicant
- Nucletron Corporation
Columbia, MD, US - Received
- April 21, 2009
- Decision date
- May 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring Ct/Mr Applicator Set,Model 110.330, cleared by the FDA?
Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring Ct/Mr Applicator Set,Model 110.330, (K091154) received a 510(k) decision of Substantially Equivalent on May 18, 2009, 27 days after the submission was received.
What is the product code of K091154?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.