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FDA 510(k)

LASERMATIC COMBOLASER MODEL 5050

K-Number: K895279 · 1989-11-08

ApplicantLasermatic OY
Decision Date1989-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERMATIC COMBOLASER MODEL 5050 is the device name listed in this FDA 510(k) record. The listed applicant is Lasermatic OY. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K895279. 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 LASERMATIC COMBOLASER MODEL 5050?

LASERMATIC COMBOLASER MODEL 5050 is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Lasermatic OY. The 510(k) number is K895279.

When did LASERMATIC COMBOLASER MODEL 5050 receive FDA 510(k) clearance?

LASERMATIC COMBOLASER MODEL 5050 received FDA 510(k) clearance on 1989-11-08, under 510(k) number K895279.

Who is the listed applicant for LASERMATIC COMBOLASER MODEL 5050?

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

What is the FDA product code for LASERMATIC COMBOLASER MODEL 5050?

The FDA product code for LASERMATIC COMBOLASER MODEL 5050 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Lasermatic OY as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K870587LASERMATIC SURGILASER MODEL 5050

Related Devices (Code: GEX)

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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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