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FDA 510(k)

SHEAUMANN PL-980

K-Number: K111360 · 2011-09-14

ApplicantSheaumann Lasers
Decision Date2011-09-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHEAUMANN PL-980 is the device name listed in this FDA 510(k) record. The listed applicant is Sheaumann Lasers. It received FDA 510(k) clearance on 2011-09-14 under 510(k) number K111360. 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 SHEAUMANN PL-980?

SHEAUMANN PL-980 is a medical device that received FDA 510(k) clearance on 2011-09-14. The listed applicant is Sheaumann Lasers. The 510(k) number is K111360.

When did SHEAUMANN PL-980 receive FDA 510(k) clearance?

SHEAUMANN PL-980 received FDA 510(k) clearance on 2011-09-14, under 510(k) number K111360.

Who is the listed applicant for SHEAUMANN PL-980?

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

What is the FDA product code for SHEAUMANN PL-980?

The FDA product code for SHEAUMANN PL-980 is GEX. This falls under the Gastroenterology category.

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Other records listing Sheaumann Lasers 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.

K111359SHEAUMANN PL-1064

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.

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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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