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FDA 510(k)

NEWGEL AND NEWGEL PLUS E

K-Number: K041704 · 2005-10-17

ApplicantNewmedical Technology, Inc.
Decision Date2005-10-17
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEWGEL AND NEWGEL PLUS E is the device name listed in this FDA 510(k) record. The listed applicant is Newmedical Technology, Inc.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K041704. 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 NEWGEL AND NEWGEL PLUS E?

NEWGEL AND NEWGEL PLUS E is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Newmedical Technology, Inc.. The 510(k) number is K041704.

When did NEWGEL AND NEWGEL PLUS E receive FDA 510(k) clearance?

NEWGEL AND NEWGEL PLUS E received FDA 510(k) clearance on 2005-10-17, under 510(k) number K041704.

Who is the listed applicant for NEWGEL AND NEWGEL PLUS E?

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

What is the FDA product code for NEWGEL AND NEWGEL PLUS E?

The FDA product code for NEWGEL AND NEWGEL PLUS E is MDA.

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Other records listing Newmedical Technology, 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.

K040064NEWMEDICAL MICRO BONE DISTRACTOR/FIXATORK030485NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

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.K040307HANSON SCAR ADEHanson Medical, 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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