ULTRAPRO COMFORT PLUG

Mesh, Surgical, Polymeric

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ultrapro Comfort Plug.

Pre-market Notification Details

• Device ID: K133198
• 510k Number: K133198
• Device Name: ULTRAPRO COMFORT PLUG
• Classification: Mesh, Surgical, Polymeric
• Applicant: ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Contact: Reynaldo Librojo
• Correspondent: Reynaldo Librojo; ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-17
• Decision Date: 2014-05-30
• Summary: summary