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FDA 510(k)

MODEL MC 1100 SURGICAL YAG LASER

K-Number: K903943 · 1990-11-21

ApplicantKlinger Micro-Controle Group
Decision Date1990-11-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL MC 1100 SURGICAL YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Klinger Micro-Controle Group. It received FDA 510(k) clearance on 1990-11-21 under 510(k) number K903943. 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 MODEL MC 1100 SURGICAL YAG LASER?

MODEL MC 1100 SURGICAL YAG LASER is a medical device that received FDA 510(k) clearance on 1990-11-21. The listed applicant is Klinger Micro-Controle Group. The 510(k) number is K903943.

When did MODEL MC 1100 SURGICAL YAG LASER receive FDA 510(k) clearance?

MODEL MC 1100 SURGICAL YAG LASER received FDA 510(k) clearance on 1990-11-21, under 510(k) number K903943.

Who is the listed applicant for MODEL MC 1100 SURGICAL YAG LASER?

The FDA 510(k) record lists Klinger Micro-Controle Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL MC 1100 SURGICAL YAG LASER?

The FDA product code for MODEL MC 1100 SURGICAL YAG LASER is GEX. This falls under the Gastroenterology category.

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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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