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FDA 510(k)

EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS

K-Number: K981045 · 1998-05-20

ApplicantExmoor Plastics , Ltd.
Decision Date1998-05-20
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EXMOOR TEFLON LOOP REPLACEMENT 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 1998-05-20 under 510(k) number K981045. 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 EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS?

EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K981045.

When did EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS receive FDA 510(k) clearance?

EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981045.

Who is the listed applicant for EXMOOR TEFLON LOOP REPLACEMENT 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 EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS?

The FDA product code for EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS is ETB.

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Other records listing Exmoor Plastics , Ltd. as applicant

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Related Devices (Code: ETB)

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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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