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FDA 510(k)

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT

K-Number: K895502 · 1989-12-08

ApplicantMicrobio-Medics, Inc.
Decision Date1989-12-08
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Microbio-Medics, Inc.. It received FDA 510(k) clearance on 1989-12-08 under 510(k) number K895502. 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 REUTER-STYLE BI-VALVE INTRANASAL SPLINT?

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT is a medical device that received FDA 510(k) clearance on 1989-12-08. The listed applicant is Microbio-Medics, Inc.. The 510(k) number is K895502.

When did MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT receive FDA 510(k) clearance?

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT received FDA 510(k) clearance on 1989-12-08, under 510(k) number K895502.

Who is the listed applicant for MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT?

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

What is the FDA product code for MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT?

The FDA product code for MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT is EPP.

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Other records listing Microbio-Medics, Inc. as applicant

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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.K890599HOOD NASAL SPLINTHood LaboratoriesK882244RICHARDS THERMOPLASTIC DORSAL NASAL SPLINTRichards Medical Co., Inc.K872905AMERICAN NASAL SPONGEAmerican Silk Sutures, Inc.K864932'EXMOOR' CAWOOD NASAL SPLINTSExmoor Plastics , Ltd.

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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