Nextec Fiberoptic Illuminat 150 WATT/HALO/3500 Kel

FDA 510(k) K920167 · Nextec Corp.

Substantially Equivalent

510(k) numberK920167

Submission

Device name
Nextec Fiberoptic Illuminat 150 WATT/HALO/3500 Kel
Applicant
Nextec Corp.
Naples, FL, US
Received
January 10, 1992
Decision date
March 23, 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
HBI – Illuminator, Fiberoptic, Surgical Field
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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More from Endomedix

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Questions and answers

When was Nextec Fiberoptic Illuminat 150 WATT/HALO/3500 Kel cleared by the FDA?

Nextec Fiberoptic Illuminat 150 WATT/HALO/3500 Kel (K920167) received a 510(k) decision of Substantially Equivalent on March 23, 1992, 73 days after the submission was received.

What is the product code of K920167?

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