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FDA 510(k)

OLEEVA FABRIC

K-Number: K023136 · 2002-10-16

ApplicantBio Med Sciences, Inc.
Decision Date2002-10-16
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OLEEVA FABRIC is the device name listed in this FDA 510(k) record. The listed applicant is Bio Med Sciences, Inc.. It received FDA 510(k) clearance on 2002-10-16 under 510(k) number K023136. 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 OLEEVA FABRIC?

OLEEVA FABRIC is a medical device that received FDA 510(k) clearance on 2002-10-16. The listed applicant is Bio Med Sciences, Inc.. The 510(k) number is K023136.

When did OLEEVA FABRIC receive FDA 510(k) clearance?

OLEEVA FABRIC received FDA 510(k) clearance on 2002-10-16, under 510(k) number K023136.

Who is the listed applicant for OLEEVA FABRIC?

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

What is the FDA product code for OLEEVA FABRIC?

The FDA product code for OLEEVA FABRIC is MDA.

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Other records listing Bio Med Sciences, 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.

K002109OLEEVA FOAMK990042SILON DUAL-DRESSK982036SILON SCAR STRIPSK952546SILON SILICONE TEXTILE COMPOSITEK946362SILON SILICONE FOAM SHEETINGK945892SILON(R) SILICONE THERMOPLASTIC SHEETING

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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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