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FDA 510(k)

DeRoyal Laprador Specimen Retrieval System

K-Number: K171475 · 2017-08-17

ApplicantDeroyal Industries, Inc.
Decision Date2017-08-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DeRoyal Laprador Specimen Retrieval System is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171475. 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 DeRoyal Laprador Specimen Retrieval System?

DeRoyal Laprador Specimen Retrieval System is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K171475.

When did DeRoyal Laprador Specimen Retrieval System receive FDA 510(k) clearance?

DeRoyal Laprador Specimen Retrieval System received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171475.

Who is the listed applicant for DeRoyal Laprador Specimen Retrieval System?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeRoyal Laprador Specimen Retrieval System?

The FDA product code for DeRoyal Laprador Specimen Retrieval 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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