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FDA 510(k)

GLOWING SPIRITS

K-Number: K951239 · 1995-07-19

ApplicantOrmco Corp.
Decision Date1995-07-19
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLOWING SPIRITS is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K951239. 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 GLOWING SPIRITS?

GLOWING SPIRITS is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Ormco Corp.. The 510(k) number is K951239.

When did GLOWING SPIRITS receive FDA 510(k) clearance?

GLOWING SPIRITS received FDA 510(k) clearance on 1995-07-19, under 510(k) number K951239.

Who is the listed applicant for GLOWING SPIRITS?

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 GLOWING SPIRITS?

The FDA product code for GLOWING SPIRITS is DYW.

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Other records listing Ormco Corp. as applicant

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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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