Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)

K-Number: K013525 · 2002-10-04

ApplicantColoplast Corp.
Decision Date2002-10-04
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2002-10-04 under 510(k) number K013525. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)?

CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) is a medical device that received FDA 510(k) clearance on 2002-10-04. The listed applicant is Coloplast Corp.. The 510(k) number is K013525.

When did CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) receive FDA 510(k) clearance?

CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) received FDA 510(k) clearance on 2002-10-04, under 510(k) number K013525.

Who is the listed applicant for CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)?

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

What is the FDA product code for CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)?

The FDA product code for CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) is MGQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Coloplast 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.

K252140Heylo™ SystemK251116Luja CoudéK250270Luja SetK242049SureCath SetK241210Luja CoudeK242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

View all 54 devices →

Related Devices (Code: MGQ)

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.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET ACTIVEMedline Industries, 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.

↑