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FDA 510(k)

Quantum LB

K-Number: K161684 · 2016-10-06

ApplicantReliance Orthodontic Products, Inc.
Decision Date2016-10-06
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Quantum LB is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K161684. 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 Quantum LB?

Quantum LB is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K161684.

When did Quantum LB receive FDA 510(k) clearance?

Quantum LB received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161684.

Who is the listed applicant for Quantum LB?

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

What is the FDA product code for Quantum LB?

The FDA product code for Quantum LB is DYH.

Other records listing Reliance Orthodontic Products, Inc. as applicant

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Related Devices (Code: DYH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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