FDA 510(k)

V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR

K-Number: K895395 · 1989-10-19

Decision Date1989-10-19

Product CodeGZT

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895395. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR?

V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K895395.

When did V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR receive FDA 510(k) clearance?

V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895395.

Who is the listed applicant for V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR?

The FDA product code for V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR is GZT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.