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FDA 510(k)

F300 SERIES CONTACT FIBER HANDPIECES

K-Number: K901021 · 1990-04-13

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1990-04-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

F300 SERIES CONTACT FIBER HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1990-04-13 under 510(k) number K901021. 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 F300 SERIES CONTACT FIBER HANDPIECES?

F300 SERIES CONTACT FIBER HANDPIECES is a medical device that received FDA 510(k) clearance on 1990-04-13. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K901021.

When did F300 SERIES CONTACT FIBER HANDPIECES receive FDA 510(k) clearance?

F300 SERIES CONTACT FIBER HANDPIECES received FDA 510(k) clearance on 1990-04-13, under 510(k) number K901021.

Who is the listed applicant for F300 SERIES CONTACT FIBER HANDPIECES?

The FDA 510(k) record lists Hgm Medical Laser Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F300 SERIES CONTACT FIBER HANDPIECES?

The FDA product code for F300 SERIES CONTACT FIBER HANDPIECES is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm Medical Laser Systems, Inc. as applicant

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Related Devices (Code: GEX)

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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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