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FDA 510(k)

HANSON SCAR ADE

K-Number: K040307 · 2004-08-12

ApplicantHanson Medical, Inc.
Decision Date2004-08-12
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANSON SCAR ADE is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K040307. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANSON SCAR ADE?

HANSON SCAR ADE is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K040307.

When did HANSON SCAR ADE receive FDA 510(k) clearance?

HANSON SCAR ADE received FDA 510(k) clearance on 2004-08-12, under 510(k) number K040307.

Who is the listed applicant for HANSON SCAR ADE?

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

What is the FDA product code for HANSON SCAR ADE?

The FDA product code for HANSON SCAR ADE is MDA.

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Other records listing Hanson Medical, 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.

K090803HANSON MEDICAL FACIAL IMPLANTSK071018MONARCH NASAL IMPLANTK041690MONARCH NASAL IMPLANTK030809HANSON MEDICAL GLUTEAL IMPLANTK030808HANSON MEDICAL CALF IMPLANTK973729POWERFLEX PEC IMPLANT

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Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K024057CURAD SCAR THERAPYBeiersdorf, Inc.

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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