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FDA 510(k)

'EXMOOR' SHAH SILICONE DISCS

K-Number: K864934 · 1987-01-28

ApplicantExmoor Plastics , Ltd.
Decision Date1987-01-28
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

'EXMOOR' SHAH SILICONE DISCS 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 1987-01-28 under 510(k) number K864934. The device is classified under product code EPP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 'EXMOOR' SHAH SILICONE DISCS?

'EXMOOR' SHAH SILICONE DISCS is a medical device that received FDA 510(k) clearance on 1987-01-28. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K864934.

When did 'EXMOOR' SHAH SILICONE DISCS receive FDA 510(k) clearance?

'EXMOOR' SHAH SILICONE DISCS received FDA 510(k) clearance on 1987-01-28, under 510(k) number K864934.

Who is the listed applicant for 'EXMOOR' SHAH SILICONE DISCS?

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' SHAH SILICONE DISCS?

The FDA product code for 'EXMOOR' SHAH SILICONE DISCS is EPP.

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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: EPP)

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.

K942158AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITSWfr/Aquaplast Corp.K942724EXTERNAL NASAL SPLINTMicromed Development Corp.K895502MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINTMicrobio-Medics, Inc.K890599HOOD NASAL SPLINTHood LaboratoriesK882244RICHARDS THERMOPLASTIC DORSAL NASAL SPLINTRichards Medical Co., Inc.K872905AMERICAN NASAL SPONGEAmerican Silk Sutures, Inc.

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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