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FDA 510(k)

VARIOUS AURAL GROMMETS

K-Number: K812460 · 1981-09-21

ApplicantExmoor Plastics , Ltd.
Decision Date1981-09-21
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VARIOUS AURAL GROMMETS 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 1981-09-21 under 510(k) number K812460. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIOUS AURAL GROMMETS?

VARIOUS AURAL GROMMETS is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K812460.

When did VARIOUS AURAL GROMMETS receive FDA 510(k) clearance?

VARIOUS AURAL GROMMETS received FDA 510(k) clearance on 1981-09-21, under 510(k) number K812460.

Who is the listed applicant for VARIOUS AURAL GROMMETS?

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 VARIOUS AURAL GROMMETS?

The FDA product code for VARIOUS AURAL GROMMETS is ETD.

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Other records listing Exmoor Plastics , Ltd. as applicant

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.

K093863EPIDRUMK990366EXMOOR SUCTION CLEARANCE KITK980828EXMOOR MYRINGOTOMY KITK981143DILKES LASER/SUCTION CANNULAEK972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESIS

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Related Devices (Code: ETD)

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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