Visionary 2000

FDA 510(k) K000639 · Burton Medical Products Corp.

Substantially Equivalent

510(k) numberK000639

Submission

Device name
Visionary 2000
Applicant
Burton Medical Products Corp.
Chatsworth, CA, US
Received
February 25, 2000
Decision date
May 25, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FSY – Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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Questions and answers

When was Visionary 2000 cleared by the FDA?

Visionary 2000 (K000639) received a 510(k) decision of Substantially Equivalent on May 25, 2000, 90 days after the submission was received.

What is the product code of K000639?

The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.