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FDA 510(k)

ALEXIS WOUND RETRACTOR

K-Number: K031889 · 2003-09-22

ApplicantApplied Medical Resources Corp.
Decision Date2003-09-22
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALEXIS WOUND RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K031889. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALEXIS WOUND RETRACTOR?

ALEXIS WOUND RETRACTOR is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K031889.

When did ALEXIS WOUND RETRACTOR receive FDA 510(k) clearance?

ALEXIS WOUND RETRACTOR received FDA 510(k) clearance on 2003-09-22, under 510(k) number K031889.

Who is the listed applicant for ALEXIS WOUND RETRACTOR?

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

What is the FDA product code for ALEXIS WOUND RETRACTOR?

The FDA product code for ALEXIS WOUND RETRACTOR is KKX.

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Official Source

View on FDA Database →

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

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