Question 1

Who is the manufacturer of MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS?

Accepted Answer

Ethicon Endo-Sugery, LLC submitted the Traditional clearance for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS (K082278).

Question 2

What is the FDA product code for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS?

Accepted Answer

NEU. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS cleared by the FDA?

Accepted Answer

Dec 16, 2008 (decision: SESE).

Question 4

What is the regulatory pathway for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS?

Accepted Answer

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

Record ID	K082278
Device Name	MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
Applicant	Ethicon Endo-Sugery, LLC
Product Code	NEU · General, Plastic Surgery
Decision Date	Dec 16, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS

Device Facts