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FDA 510(k)

KELO-COTE SPRAY

K-Number: K053481 · 2006-04-14

ApplicantAdvanced Bio-Technologies, Inc.
Decision Date2006-04-14
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KELO-COTE SPRAY is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bio-Technologies, Inc.. It received FDA 510(k) clearance on 2006-04-14 under 510(k) number K053481. 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 KELO-COTE SPRAY?

KELO-COTE SPRAY is a medical device that received FDA 510(k) clearance on 2006-04-14. The listed applicant is Advanced Bio-Technologies, Inc.. The 510(k) number is K053481.

When did KELO-COTE SPRAY receive FDA 510(k) clearance?

KELO-COTE SPRAY received FDA 510(k) clearance on 2006-04-14, under 510(k) number K053481.

Who is the listed applicant for KELO-COTE SPRAY?

The FDA 510(k) record lists Advanced Bio-Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KELO-COTE SPRAY?

The FDA product code for KELO-COTE SPRAY is MDA.

Related Clinical Trials

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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Other records listing Advanced Bio-Technologies, 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.

K002488KELO-COTE TOPICAL GEL

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, LLCK041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, 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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