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FDA 510(k)

BARLE TISSUE ADHESIVE

K-Number: K123133 · 2013-05-22

ApplicantAdvanced Medical Solutions (Plymouth), Ltd.
Decision Date2013-05-22
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARLE TISSUE ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions (Plymouth), Ltd.. It received FDA 510(k) clearance on 2013-05-22 under 510(k) number K123133. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARLE TISSUE ADHESIVE?

BARLE TISSUE ADHESIVE is a medical device that received FDA 510(k) clearance on 2013-05-22. The listed applicant is Advanced Medical Solutions (Plymouth), Ltd.. The 510(k) number is K123133.

When did BARLE TISSUE ADHESIVE receive FDA 510(k) clearance?

BARLE TISSUE ADHESIVE received FDA 510(k) clearance on 2013-05-22, under 510(k) number K123133.

Who is the listed applicant for BARLE TISSUE ADHESIVE?

The FDA 510(k) record lists Advanced Medical Solutions (Plymouth), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARLE TISSUE ADHESIVE?

The FDA product code for BARLE TISSUE ADHESIVE is MPN.

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 Medical Solutions (Plymouth), Ltd. 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.

K132243BARLE TISSUE ADHESIVE 2K122446LIQUIDBAND FLOW CONTROL

Related Devices (Code: MPN)

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.

K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant MedicalK234114CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant MedicalK233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.K212246Exofin Precision PenChemence Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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