FDA 510(k)

NITANIUM PALATAL EXPANDER

K-Number: K923218 · 1993-09-13

Decision Date1993-09-13

Product CodeEJF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NITANIUM PALATAL EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 1993-09-13 under 510(k) number K923218. 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 NITANIUM PALATAL EXPANDER?

NITANIUM PALATAL EXPANDER is a medical device that received FDA 510(k) clearance on 1993-09-13. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K923218.

When did NITANIUM PALATAL EXPANDER receive FDA 510(k) clearance?

NITANIUM PALATAL EXPANDER received FDA 510(k) clearance on 1993-09-13, under 510(k) number K923218.

Who is the listed applicant for NITANIUM PALATAL EXPANDER?

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

What is the FDA product code for NITANIUM PALATAL EXPANDER?

The FDA product code for NITANIUM PALATAL EXPANDER is 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.