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FDA 510(k)

ALGOPLAQUE HYDROCOLLOID DRESSING

K-Number: K970518 · 1997-03-21

ApplicantLaboratoires Urgo S.A.
Decision Date1997-03-21
Product CodeMGP
DecisionSubstantially Equivalent for Some Indications

Device Summary

ALGOPLAQUE HYDROCOLLOID DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoires Urgo S.A.. It received FDA 510(k) clearance on 1997-03-21 under 510(k) number K970518. The device is classified under product code MGP. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ALGOPLAQUE HYDROCOLLOID DRESSING?

ALGOPLAQUE HYDROCOLLOID DRESSING is a medical device that received FDA 510(k) clearance on 1997-03-21. The listed applicant is Laboratoires Urgo S.A.. The 510(k) number is K970518.

When did ALGOPLAQUE HYDROCOLLOID DRESSING receive FDA 510(k) clearance?

ALGOPLAQUE HYDROCOLLOID DRESSING received FDA 510(k) clearance on 1997-03-21, under 510(k) number K970518.

Who is the listed applicant for ALGOPLAQUE HYDROCOLLOID DRESSING?

The FDA 510(k) record lists Laboratoires Urgo S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGOPLAQUE HYDROCOLLOID DRESSING?

The FDA product code for ALGOPLAQUE HYDROCOLLOID DRESSING is MGP.

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 Laboratoires Urgo S.A. 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.

K974348ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING

Related Devices (Code: MGP)

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.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, 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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