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FDA 510(k)

GRENGLOO

K-Number: K061481 · 2006-07-06

ApplicantOrmco Corp.
Decision Date2006-07-06
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRENGLOO is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 2006-07-06 under 510(k) number K061481. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRENGLOO?

GRENGLOO is a medical device that received FDA 510(k) clearance on 2006-07-06. The listed applicant is Ormco Corp.. The 510(k) number is K061481.

When did GRENGLOO receive FDA 510(k) clearance?

GRENGLOO received FDA 510(k) clearance on 2006-07-06, under 510(k) number K061481.

Who is the listed applicant for GRENGLOO?

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 GRENGLOO?

The FDA product code for GRENGLOO is DYH.

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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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