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FDA 510(k)

CONBIO CUB-D10 COOPER LASER SYSTEM

K-Number: K942934 · 1994-09-27

ApplicantContinuum Biomedical, Inc.
Decision Date1994-09-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONBIO CUB-D10 COOPER LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K942934. 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 CONBIO CUB-D10 COOPER LASER SYSTEM?

CONBIO CUB-D10 COOPER LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K942934.

When did CONBIO CUB-D10 COOPER LASER SYSTEM receive FDA 510(k) clearance?

CONBIO CUB-D10 COOPER LASER SYSTEM received FDA 510(k) clearance on 1994-09-27, under 510(k) number K942934.

Who is the listed applicant for CONBIO CUB-D10 COOPER LASER SYSTEM?

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

What is the FDA product code for CONBIO CUB-D10 COOPER LASER SYSTEM?

The FDA product code for CONBIO CUB-D10 COOPER LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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