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FDA 510(k)

FIXATION TROCARS

K-Number: K083638 · 2008-12-23

ApplicantApplied Medical Resources Corp.
Decision Date2008-12-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIXATION TROCARS 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 2008-12-23 under 510(k) number K083638. 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 FIXATION TROCARS?

FIXATION TROCARS is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K083638.

When did FIXATION TROCARS receive FDA 510(k) clearance?

FIXATION TROCARS received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083638.

Who is the listed applicant for FIXATION TROCARS?

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 FIXATION TROCARS?

The FDA product code for FIXATION TROCARS 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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