Biolucent Applicator Kit

FDA 510(k) K062830 · Biolucent, Inc.

Substantially Equivalent

510(k) numberK062830

Submission

Device name
Biolucent Applicator Kit
Applicant
Biolucent, Inc.
Aliso Viejo, CA, US
Received
September 20, 2006
Decision date
October 20, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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More from Braxx Biotech Co., Ltd.

510(k)DeviceDecision
K070659Biolucent Applicator KitJAQ · Special 04/04/2007SESU
K062141Mammopad Radiolucent CushionIYX · Traditional 09/13/2006SE
K061241Biolucent Applicator, Model Rta-XxJAQ · Traditional 07/28/2006SE
K053595Curay Custom Seed ArrayKXK · Traditional 02/28/2006SE
K003795Biolucent Mammography CushionIZH · Traditional 02/14/2001SE

Questions and answers

When was Biolucent Applicator Kit cleared by the FDA?

Biolucent Applicator Kit (K062830) received a 510(k) decision of Substantially Equivalent on October 20, 2006, 30 days after the submission was received.

What is the product code of K062830?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.