Eazy Covers
FDA 510(k) K863853 · Superior Medical Products
510(k) numberK863853
Submission
- Device name
- Eazy Covers
- Applicant
- Superior Medical Products
Marietta, GA, US - Received
- October 2, 1986
- Decision date
- March 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Eazy Covers cleared by the FDA?
Eazy Covers (K863853) received a 510(k) decision of Substantially Equivalent on March 6, 1987, 155 days after the submission was received.
What is the product code of K863853?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.