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FDA 510(k)

SPIRIT MB

K-Number: K955333 · 1996-01-04

ApplicantOrmco Corp.
Decision Date1996-01-04
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPIRIT MB is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K955333. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRIT MB?

SPIRIT MB is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Ormco Corp.. The 510(k) number is K955333.

When did SPIRIT MB receive FDA 510(k) clearance?

SPIRIT MB received FDA 510(k) clearance on 1996-01-04, under 510(k) number K955333.

Who is the listed applicant for SPIRIT MB?

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 SPIRIT MB?

The FDA product code for SPIRIT MB is DYW.

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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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