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FDA 510(k)

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

K-Number: K163247 · 2017-03-09

ApplicantLaurimed, LLC
Decision Date2017-03-09
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is the device name listed in this FDA 510(k) record. The listed applicant is Laurimed, LLC. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K163247. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider?

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Laurimed, LLC. The 510(k) number is K163247.

When did 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider receive FDA 510(k) clearance?

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider received FDA 510(k) clearance on 2017-03-09, under 510(k) number K163247.

Who is the listed applicant for 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider?

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

What is the FDA product code for 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider?

The FDA product code for 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is ERL.

Other records listing Laurimed, LLC 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.

Related Devices (Code: ERL)

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

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