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FDA 510(k)

HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL

K-Number: K902645 · 1990-09-06

ApplicantOrmco Corp.
Decision Date1990-09-06
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1990-09-06 under 510(k) number K902645. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL?

HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL is a medical device that received FDA 510(k) clearance on 1990-09-06. The listed applicant is Ormco Corp.. The 510(k) number is K902645.

When did HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL receive FDA 510(k) clearance?

HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL received FDA 510(k) clearance on 1990-09-06, under 510(k) number K902645.

Who is the listed applicant for HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL?

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 HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL?

The FDA product code for HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL is DZB.

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Related Devices (Code: DZB)

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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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