Namic Contrast Savings Delivery System
FDA 510(k) K903493 · North American Instrument Corp.
510(k) numberK903493
Submission
- Device name
- Namic Contrast Savings Delivery System
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- August 3, 1990
- Decision date
- March 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Namic Contrast Savings Delivery System cleared by the FDA?
Namic Contrast Savings Delivery System (K903493) received a 510(k) decision of Substantially Equivalent on March 26, 1991, 235 days after the submission was received.
What is the product code of K903493?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.