Advance Disposable Control Syringe
FDA 510(k) K911732 · Advance Medical Designs, Inc.
510(k) numberK911732
Submission
- Device name
- Advance Disposable Control Syringe
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- April 17, 1991
- Decision date
- September 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Advance Disposable Control Syringe cleared by the FDA?
Advance Disposable Control Syringe (K911732) received a 510(k) decision of Substantially Equivalent on September 16, 1991, 152 days after the submission was received.
What is the product code of K911732?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.