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FDA 510(k)

OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES

K-Number: K944704 · 1995-01-06

ApplicantXintec Corporation
Decision Date1995-01-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1995-01-06 under 510(k) number K944704. 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 OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES?

OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-01-06. The listed applicant is Xintec Corporation. The 510(k) number is K944704.

When did OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES receive FDA 510(k) clearance?

OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES received FDA 510(k) clearance on 1995-01-06, under 510(k) number K944704.

Who is the listed applicant for OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES?

The FDA 510(k) record lists Xintec Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES?

The FDA product code for OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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

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