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FDA 510(k)

ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR

K-Number: K872589 · 1987-09-11

ApplicantClass, Inc.
Decision Date1987-09-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Class, Inc.. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K872589. 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 ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR?

ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Class, Inc.. The 510(k) number is K872589.

When did ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR receive FDA 510(k) clearance?

ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR received FDA 510(k) clearance on 1987-09-11, under 510(k) number K872589.

Who is the listed applicant for ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR?

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

What is the FDA product code for ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR?

The FDA product code for ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR 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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