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FDA 510(k)

FLOUROSHIELD RADIATION REDUCTION GLOVE

K-Number: K893093 · 1990-02-13

ApplicantAcufex Microsurgical, Inc.
Decision Date1990-02-13
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLOUROSHIELD RADIATION REDUCTION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1990-02-13 under 510(k) number K893093. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOUROSHIELD RADIATION REDUCTION GLOVE?

FLOUROSHIELD RADIATION REDUCTION GLOVE is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K893093.

When did FLOUROSHIELD RADIATION REDUCTION GLOVE receive FDA 510(k) clearance?

FLOUROSHIELD RADIATION REDUCTION GLOVE received FDA 510(k) clearance on 1990-02-13, under 510(k) number K893093.

Who is the listed applicant for FLOUROSHIELD RADIATION REDUCTION GLOVE?

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

What is the FDA product code for FLOUROSHIELD RADIATION REDUCTION GLOVE?

The FDA product code for FLOUROSHIELD RADIATION REDUCTION GLOVE is LZC.

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Other records listing Acufex Microsurgical, 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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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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