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FDA 510(k)

MEPILEX

K-Number: K983184 · 1998-10-28

Decision Date1998-10-28
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

MEPILEX is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care, Inc.. It received FDA 510(k) clearance on 1998-10-28 under 510(k) number K983184. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEPILEX?

MEPILEX is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Molnlycke Health Care, Inc.. The 510(k) number is K983184.

When did MEPILEX receive FDA 510(k) clearance?

MEPILEX received FDA 510(k) clearance on 1998-10-28, under 510(k) number K983184.

Who is the listed applicant for MEPILEX?

The FDA 510(k) record lists Molnlycke Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEPILEX?

The FDA product code for MEPILEX 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.

Other records listing Molnlycke Health Care, 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.

View all 10 devices →

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.

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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