FDA 510(k)

MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT

K-Number: K041381 · 2004-09-10

Decision Date2004-09-10

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K041381. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K041381.

When did MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT receive FDA 510(k) clearance?

MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT received FDA 510(k) clearance on 2004-09-10, under 510(k) number K041381.

Who is the listed applicant for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

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

What is the FDA product code for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

The FDA product code for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT is LYA.

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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.