Lollipop BiteBlock

FDA 510(k) K200652 · Radtec Medical Devices, Inc.

Substantially Equivalent

510(k) numberK200652

Submission

Device name
Lollipop BiteBlock
Applicant
Radtec Medical Devices, Inc.
San Carlos, CA, US
Received
March 12, 2020
Decision date
July 6, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Lollipop BiteBlock cleared by the FDA?

Lollipop BiteBlock (K200652) received a 510(k) decision of Substantially Equivalent on July 6, 2020, 116 days after the submission was received.

What is the product code of K200652?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.