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FDA 510(k)

Lollipop BiteBlock

K-Number: K200652 · 2020-07-06

ApplicantRadtec Medical Devices, Inc.
Decision Date2020-07-06
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lollipop BiteBlock is the device name listed in this FDA 510(k) record. The listed applicant is Radtec Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-07-06 under 510(k) number K200652. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lollipop BiteBlock?

Lollipop BiteBlock is a medical device that received FDA 510(k) clearance on 2020-07-06. The listed applicant is Radtec Medical Devices, Inc.. The 510(k) number is K200652.

When did Lollipop BiteBlock receive FDA 510(k) clearance?

Lollipop BiteBlock received FDA 510(k) clearance on 2020-07-06, under 510(k) number K200652.

Who is the listed applicant for Lollipop BiteBlock?

The FDA 510(k) record lists Radtec Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lollipop BiteBlock?

The FDA product code for Lollipop BiteBlock is IYE.

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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