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FDA 510(k)

FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)

K-Number: K032667 · 2004-01-23

ApplicantFocus Medical, LLC
Decision Date2004-01-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) is the device name listed in this FDA 510(k) record. The listed applicant is Focus Medical, LLC. It received FDA 510(k) clearance on 2004-01-23 under 510(k) number K032667. 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 FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)?

FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) is a medical device that received FDA 510(k) clearance on 2004-01-23. The listed applicant is Focus Medical, LLC. The 510(k) number is K032667.

When did FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) receive FDA 510(k) clearance?

FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) received FDA 510(k) clearance on 2004-01-23, under 510(k) number K032667.

Who is the listed applicant for FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)?

The FDA 510(k) record lists Focus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)?

The FDA product code for FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) 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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