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FDA 510(k)

MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES

K-Number: K885291 · 1989-02-03

ApplicantPfizer Laser Systems
Decision Date1989-02-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Laser Systems. It received FDA 510(k) clearance on 1989-02-03 under 510(k) number K885291. 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 20-CH CARBON DIOXIDE LASER W/ACCESSORIES?

MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Pfizer Laser Systems. The 510(k) number is K885291.

When did MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES receive FDA 510(k) clearance?

MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES received FDA 510(k) clearance on 1989-02-03, under 510(k) number K885291.

Who is the listed applicant for MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES?

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

What is the FDA product code for MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES?

The FDA product code for MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Pfizer Laser Systems 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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