Titanium Suction Tip
FDA 510(k) K874401 · Implant Innovations International, Inc.
510(k) numberK874401
Submission
- Device name
- Titanium Suction Tip
- Applicant
- Implant Innovations International, Inc.
West Palm Beach, FL, US - Received
- October 28, 1987
- Decision date
- November 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Titanium Suction Tip cleared by the FDA?
Titanium Suction Tip (K874401) received a 510(k) decision of Substantially Equivalent on November 12, 1987, 15 days after the submission was received.
What is the product code of K874401?
The FDA product code is EHZ – Evacuator, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6640.