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FDA 510(k)

CENTAURI

K-Number: K983211 · 1998-10-09

ApplicantPremier Laser Systems, Inc.
Decision Date1998-10-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CENTAURI is the device name listed in this FDA 510(k) record. The listed applicant is Premier Laser Systems, Inc.. It received FDA 510(k) clearance on 1998-10-09 under 510(k) number K983211. 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 CENTAURI?

CENTAURI is a medical device that received FDA 510(k) clearance on 1998-10-09. The listed applicant is Premier Laser Systems, Inc.. The 510(k) number is K983211.

When did CENTAURI receive FDA 510(k) clearance?

CENTAURI received FDA 510(k) clearance on 1998-10-09, under 510(k) number K983211.

Who is the listed applicant for CENTAURI?

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

What is the FDA product code for CENTAURI?

The FDA product code for CENTAURI is GEX. This falls under the Gastroenterology category.

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Other records listing Premier Laser Systems, Inc. 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.

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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

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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