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FDA 510(k)

MICROTEK INTRANASAL SPLINT

K-Number: K862496 · 1986-07-14

ApplicantMicrotek Medical, Inc.
Decision Date1986-07-14
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICROTEK INTRANASAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K862496. 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 MICROTEK INTRANASAL SPLINT?

MICROTEK INTRANASAL SPLINT is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K862496.

When did MICROTEK INTRANASAL SPLINT receive FDA 510(k) clearance?

MICROTEK INTRANASAL SPLINT received FDA 510(k) clearance on 1986-07-14, under 510(k) number K862496.

Who is the listed applicant for MICROTEK INTRANASAL SPLINT?

The FDA 510(k) record lists Microtek Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTEK INTRANASAL SPLINT?

The FDA product code for MICROTEK INTRANASAL SPLINT is EPP.

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Other records listing Microtek Medical, Inc. 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.

K110358VENODYNE V810K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKK062899MICROTEK MEDICAL SURGICAL GOWN/TOGAK060200MICROTEK MEDICAL WARMING DRAPEK050322MICROTEK EQUIPMENT DRAPESK022903CHILLBUSTER

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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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