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FDA 510(k)

MEPILEX BORDER AG DRESSING

K-Number: K100029 · 2010-09-15

ApplicantMolnlycke Health Care
Decision Date2010-09-15
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MEPILEX BORDER AG DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care. It received FDA 510(k) clearance on 2010-09-15 under 510(k) number K100029. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEPILEX BORDER AG DRESSING?

MEPILEX BORDER AG DRESSING is a medical device that received FDA 510(k) clearance on 2010-09-15. The listed applicant is Molnlycke Health Care. The 510(k) number is K100029.

When did MEPILEX BORDER AG DRESSING receive FDA 510(k) clearance?

MEPILEX BORDER AG DRESSING received FDA 510(k) clearance on 2010-09-15, under 510(k) number K100029.

Who is the listed applicant for MEPILEX BORDER AG DRESSING?

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

What is the FDA product code for MEPILEX BORDER AG DRESSING?

The FDA product code for MEPILEX BORDER AG DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Molnlycke Health Care 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.

K123892MEPILEX TRANSFER AGK122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAMK102923BARRIER N95 PARTICULATE RESPIRATORK061554MEPILEX AG ABSORBENT SILICONE-COATED DRESSINGK050786BARRIER SURGICAL GOWNSK031131KLINIDRAPE SURGICAL DRAPES

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Related Devices (Code: FRO)

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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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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