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FDA 510(k)

MUCOHARD

K-Number: K053516 · 2006-01-26

ApplicantParkell, Inc.
Decision Date2006-01-26
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MUCOHARD is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K053516. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUCOHARD?

MUCOHARD is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Parkell, Inc.. The 510(k) number is K053516.

When did MUCOHARD receive FDA 510(k) clearance?

MUCOHARD received FDA 510(k) clearance on 2006-01-26, under 510(k) number K053516.

Who is the listed applicant for MUCOHARD?

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

What is the FDA product code for MUCOHARD?

The FDA product code for MUCOHARD is EBI.

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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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