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FDA 510(k)

'EXMOOR' SHAH & MACKAY NASAL SPLINTS

K-Number: K864933 · 1987-03-04

ApplicantExmoor Plastics , Ltd.
Decision Date1987-03-04
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

'EXMOOR' SHAH & MACKAY NASAL SPLINTS 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 1987-03-04 under 510(k) number K864933. 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 & MACKAY NASAL SPLINTS?

'EXMOOR' SHAH & MACKAY NASAL SPLINTS is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K864933.

When did 'EXMOOR' SHAH & MACKAY NASAL SPLINTS receive FDA 510(k) clearance?

'EXMOOR' SHAH & MACKAY NASAL SPLINTS received FDA 510(k) clearance on 1987-03-04, under 510(k) number K864933.

Who is the listed applicant for 'EXMOOR' SHAH & MACKAY NASAL SPLINTS?

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 & MACKAY NASAL SPLINTS?

The FDA product code for 'EXMOOR' SHAH & MACKAY NASAL SPLINTS 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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