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FDA 510(k)

MODIFICATION TO OPTICAL SEPARATOR SYSTEM

K-Number: K041795 · 2004-09-14

ApplicantApplied Medical Resources Corp.
Decision Date2004-09-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO OPTICAL SEPARATOR SYSTEM 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 2004-09-14 under 510(k) number K041795. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO OPTICAL SEPARATOR SYSTEM?

MODIFICATION TO OPTICAL SEPARATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-14. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K041795.

When did MODIFICATION TO OPTICAL SEPARATOR SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO OPTICAL SEPARATOR SYSTEM received FDA 510(k) clearance on 2004-09-14, under 510(k) number K041795.

Who is the listed applicant for MODIFICATION TO OPTICAL SEPARATOR SYSTEM?

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 MODIFICATION TO OPTICAL SEPARATOR SYSTEM?

The FDA product code for MODIFICATION TO OPTICAL SEPARATOR SYSTEM is GCJ.

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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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