Nextec Fiberoptic Illuminator 300 Watt Xenon

FDA 510(k) K921646 · Nextec Corp.

Substantially Equivalent

510(k) numberK921646

Submission

Device name
Nextec Fiberoptic Illuminator 300 Watt Xenon
Applicant
Nextec Corp.
Naples, FL, US
Received
April 6, 1992
Decision date
May 13, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

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

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More from Bfw, Inc.

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K922462Nextec Fiberoptic CablesHBI · Traditional 09/21/1992SE
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Questions and answers

When was Nextec Fiberoptic Illuminator 300 Watt Xenon cleared by the FDA?

Nextec Fiberoptic Illuminator 300 Watt Xenon (K921646) received a 510(k) decision of Substantially Equivalent on May 13, 1992, 37 days after the submission was received.

What is the product code of K921646?

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