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FDA 510(k)

MCGEE MODIFIED STAINLESS STEEL PISTON

K-Number: K823440 · 1982-12-03

ApplicantTreace Medical, Inc.
Decision Date1982-12-03
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MCGEE MODIFIED STAINLESS STEEL PISTON is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823440. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCGEE MODIFIED STAINLESS STEEL PISTON?

MCGEE MODIFIED STAINLESS STEEL PISTON is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Treace Medical, Inc.. The 510(k) number is K823440.

When did MCGEE MODIFIED STAINLESS STEEL PISTON receive FDA 510(k) clearance?

MCGEE MODIFIED STAINLESS STEEL PISTON received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823440.

Who is the listed applicant for MCGEE MODIFIED STAINLESS STEEL PISTON?

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

What is the FDA product code for MCGEE MODIFIED STAINLESS STEEL PISTON?

The FDA product code for MCGEE MODIFIED STAINLESS STEEL PISTON is ETB.

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Other records listing Treace Medical, Inc. as applicant

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Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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