FDA 510(k)

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)

K-Number: K963899 · 1997-08-22

Decision Date1997-08-22

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) 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 1997-08-22 under 510(k) number K963899. 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 CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)?

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) is a medical device that received FDA 510(k) clearance on 1997-08-22. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K963899.

When did CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) receive FDA 510(k) clearance?

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) received FDA 510(k) clearance on 1997-08-22, under 510(k) number K963899.

Who is the listed applicant for CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)?

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 CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)?

The FDA product code for CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) is ETA.

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Other records listing Exmoor Plastics , Ltd. as applicant

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Related Devices (Code: 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.