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FDA 510(k)

LINGUAL SHEATH

K-Number: K900184 · 1990-04-02

ApplicantOrmco Corp.
Decision Date1990-04-02
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LINGUAL SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1990-04-02 under 510(k) number K900184. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINGUAL SHEATH?

LINGUAL SHEATH is a medical device that received FDA 510(k) clearance on 1990-04-02. The listed applicant is Ormco Corp.. The 510(k) number is K900184.

When did LINGUAL SHEATH receive FDA 510(k) clearance?

LINGUAL SHEATH received FDA 510(k) clearance on 1990-04-02, under 510(k) number K900184.

Who is the listed applicant for LINGUAL SHEATH?

The FDA 510(k) record lists Ormco Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINGUAL SHEATH?

The FDA product code for LINGUAL SHEATH is EJF.

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Other records listing Ormco Corp. as applicant

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Related Devices (Code: EJF)

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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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