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FDA 510(k)

KELOCATE SHEETING

K-Number: K982051 · 1998-08-05

ApplicantAllied Biomedical Corp.
Decision Date1998-08-05
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KELOCATE SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Allied Biomedical Corp.. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K982051. 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 KELOCATE SHEETING?

KELOCATE SHEETING is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Allied Biomedical Corp.. The 510(k) number is K982051.

When did KELOCATE SHEETING receive FDA 510(k) clearance?

KELOCATE SHEETING received FDA 510(k) clearance on 1998-08-05, under 510(k) number K982051.

Who is the listed applicant for KELOCATE SHEETING?

The FDA 510(k) record lists Allied Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KELOCATE SHEETING?

The FDA product code for KELOCATE SHEETING is MDA.

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Other records listing Allied Biomedical Corp. 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.

K971479DURALASTIC ANATOMICAL MALAR IMPLANTSK971478DURALASTIC ANATOMICAL CHIN IMPLANTSK971481DURALASTIC ANATOMICAL NASAL IMPLANTSK971480DURALASTIC I AND DURALASTIC IIK955370DURALASTIC IIK955368DURALASTIC I

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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.K040307HANSON SCAR ADEHanson Medical, 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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