(CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe
FDA 510(k) K901552 · Nobelpharma USA, Inc.
510(k) numberK901552
Submission
- Device name
- (CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe
- Applicant
- Nobelpharma USA, Inc.
Chicago, IL, US - Received
- April 3, 1990
- Decision date
- June 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was (CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe cleared by the FDA?
(CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe (K901552) received a 510(k) decision of Substantially Equivalent on June 24, 1991, 447 days after the submission was received.
What is the product code of K901552?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.