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FDA 510(k)

LIGHT-TOUCH AND SURGI LIGHT FIBERS

K-Number: K910726 · 1991-03-29

ApplicantLifestream Int'L, Inc.
Decision Date1991-03-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHT-TOUCH AND SURGI LIGHT FIBERS is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910726. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT-TOUCH AND SURGI LIGHT FIBERS?

LIGHT-TOUCH AND SURGI LIGHT FIBERS is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K910726.

When did LIGHT-TOUCH AND SURGI LIGHT FIBERS receive FDA 510(k) clearance?

LIGHT-TOUCH AND SURGI LIGHT FIBERS received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910726.

Who is the listed applicant for LIGHT-TOUCH AND SURGI LIGHT FIBERS?

The FDA 510(k) record lists Lifestream Int'L, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGHT-TOUCH AND SURGI LIGHT FIBERS?

The FDA product code for LIGHT-TOUCH AND SURGI LIGHT FIBERS is GEX. This falls under the Gastroenterology category.

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Other records listing Lifestream Int'L, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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