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FDA 510(k)

MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES

K-Number: K882208 · 1988-08-03

Decision Date1988-08-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES is the device name listed in this FDA 510(k) record. The listed applicant is Linde Div. Union Carbide Corp.. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K882208. 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 MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES?

MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Linde Div. Union Carbide Corp.. The 510(k) number is K882208.

When did MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES receive FDA 510(k) clearance?

MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES received FDA 510(k) clearance on 1988-08-03, under 510(k) number K882208.

Who is the listed applicant for MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES?

The FDA 510(k) record lists Linde Div. Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES?

The FDA product code for MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

Other records listing Linde Div. Union Carbide Corp. 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.

Related Devices (Code: GEX)

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.

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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