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FDA 510(k)

ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

K-Number: K000442 · 2001-04-24

ApplicantMedical Concepts Development, Inc.
Decision Date2001-04-24
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX is the device name listed in this FDA 510(k) record. The listed applicant is Medical Concepts Development, Inc.. It received FDA 510(k) clearance on 2001-04-24 under 510(k) number K000442. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX?

ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX is a medical device that received FDA 510(k) clearance on 2001-04-24. The listed applicant is Medical Concepts Development, Inc.. The 510(k) number is K000442.

When did ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX receive FDA 510(k) clearance?

ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX received FDA 510(k) clearance on 2001-04-24, under 510(k) number K000442.

Who is the listed applicant for ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX?

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

What is the FDA product code for ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX?

The FDA product code for ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX is KKX.

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Other records listing Medical Concepts Development, Inc. as applicant

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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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