FDA 510(k)

MILLS COLUMELLA PROSTHESIS

K-Number: K981088 · 1998-06-05

Decision Date1998-06-05

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

MILLS COLUMELLA PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K981088. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLS COLUMELLA PROSTHESIS?

MILLS COLUMELLA PROSTHESIS is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K981088.

When did MILLS COLUMELLA PROSTHESIS receive FDA 510(k) clearance?

MILLS COLUMELLA PROSTHESIS received FDA 510(k) clearance on 1998-06-05, under 510(k) number K981088.

Who is the listed applicant for MILLS COLUMELLA PROSTHESIS?

The FDA 510(k) record lists Exmoor Plastics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MILLS COLUMELLA PROSTHESIS?

The FDA product code for MILLS COLUMELLA PROSTHESIS is ETA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.