V. Mueller Rhoton Self-Retaining Brain Retractor
FDA 510(k) K895395 · Baxter Healthcare Corp
510(k) numberK895395
Submission
- Device name
- V. Mueller Rhoton Self-Retaining Brain Retractor
- Applicant
- Baxter Healthcare Corp
Niles, IL, US - Received
- September 1, 1989
- Decision date
- October 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was V. Mueller Rhoton Self-Retaining Brain Retractor cleared by the FDA?
V. Mueller Rhoton Self-Retaining Brain Retractor (K895395) received a 510(k) decision of Substantially Equivalent on October 19, 1989, 48 days after the submission was received.
What is the product code of K895395?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.