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FDA 510(k)

OMEGA BIVALVE NASAL SPLINTS

K-Number: K871073 · 1987-05-11

ApplicantOmega Silicone, Inc.
Decision Date1987-05-11
Product CodeFYI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMEGA BIVALVE NASAL SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Omega Silicone, Inc.. It received FDA 510(k) clearance on 1987-05-11 under 510(k) number K871073. The device is classified under product code FYI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA BIVALVE NASAL SPLINTS?

OMEGA BIVALVE NASAL SPLINTS is a medical device that received FDA 510(k) clearance on 1987-05-11. The listed applicant is Omega Silicone, Inc.. The 510(k) number is K871073.

When did OMEGA BIVALVE NASAL SPLINTS receive FDA 510(k) clearance?

OMEGA BIVALVE NASAL SPLINTS received FDA 510(k) clearance on 1987-05-11, under 510(k) number K871073.

Who is the listed applicant for OMEGA BIVALVE NASAL SPLINTS?

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

What is the FDA product code for OMEGA BIVALVE NASAL SPLINTS?

The FDA product code for OMEGA BIVALVE NASAL SPLINTS is FYI.

Related Clinical Trials

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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Other records listing Omega Silicone, 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.

K871072OMEGA NASAL SEPTAL BUTTONK871070OMEGA SILICONE CHIN IMPLANTK871071OMEGA DORSAL COLUMELLA IMPLANTSK871074OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR

Related Devices (Code: FYI)

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.

K821178ETHICON EXTERNAL FIXATION WIREETHICON, Inc.K801072STRAITH NASAL SPLINTSurgical Technology Laboratories, Inc.K792106CONPHAR O.R. HEAD COVER-STERILEConphar, 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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