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FDA 510(k)

EPOCA CUSTOM OFFSET SHOULDER SYSTEM

K-Number: K010869 · 2001-10-11

ApplicantArgomedical AG
Decision Date2001-10-11
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPOCA CUSTOM OFFSET SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Argomedical AG. It received FDA 510(k) clearance on 2001-10-11 under 510(k) number K010869. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPOCA CUSTOM OFFSET SHOULDER SYSTEM?

EPOCA CUSTOM OFFSET SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-10-11. The listed applicant is Argomedical AG. The 510(k) number is K010869.

When did EPOCA CUSTOM OFFSET SHOULDER SYSTEM receive FDA 510(k) clearance?

EPOCA CUSTOM OFFSET SHOULDER SYSTEM received FDA 510(k) clearance on 2001-10-11, under 510(k) number K010869.

Who is the listed applicant for EPOCA CUSTOM OFFSET SHOULDER SYSTEM?

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

What is the FDA product code for EPOCA CUSTOM OFFSET SHOULDER SYSTEM?

The FDA product code for EPOCA CUSTOM OFFSET SHOULDER SYSTEM is KWT.

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Related Devices (Code: KWT)

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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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