Question 1

Who is the manufacturer of LUHR MICRO MESH?

Accepted Answer

Howmedica Corp. filed the 510(k) submission for LUHR MICRO MESH (K901940).

Question 2

What is the FDA product code for LUHR MICRO MESH?

Accepted Answer

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

Question 3

When was LUHR MICRO MESH cleared by the FDA?

Accepted Answer

Sep 6, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for LUHR MICRO MESH?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like LUHR MICRO MESH?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K901940
Device Name	LUHR MICRO MESH
Applicant	Howmedica Corp.
Product Code	JEY · Dental
Decision Date	Sep 6, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2

LUHR MICRO MESH

Device Facts

Regulatory Classification

Identification