Model Cole TAB-2 Table W/Model Cole SFD-2 Spotfilm
FDA 510(k) K926407 · Nucletron-Oldelft Corp.
510(k) numberK926407
Submission
- Device name
- Model Cole TAB-2 Table W/Model Cole SFD-2 Spotfilm
- Applicant
- Nucletron-Oldelft Corp.
Urbanna, VA, US - Received
- December 21, 1992
- Decision date
- March 31, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Model Cole TAB-2 Table W/Model Cole SFD-2 Spotfilm cleared by the FDA?
Model Cole TAB-2 Table W/Model Cole SFD-2 Spotfilm (K926407) received a 510(k) decision of Substantially Equivalent on March 31, 1993, 100 days after the submission was received.
What is the product code of K926407?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.