PARIETEX

Mesh, Surgical, Polymeric

COGENT

The following data is part of a premarket notification filed by Cogent with the FDA for Parietex.

Pre-market Notification Details

• Device ID: K982532
• 510k Number: K982532
• Device Name: PARIETEX
• Classification: Mesh, Surgical, Polymeric
• Applicant: COGENT 555 THIRTEENTH ST. N.W. Washington, DC 20004
• Contact: Howard M Holstein
• Correspondent: Howard M Holstein; COGENT 555 THIRTEENTH ST. N.W. Washington, DC 20004
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-20
• Decision Date: 1999-01-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521180055	K982532	000
10884521180154	K982532	000
10884521180147	K982532	000
10884521180031	K982532	000
10884521179974	K982532	000
10884521180321	K982532	000
10884521180291	K982532	000
10884521180222	K982532	000
10884521180208	K982532	000
10884521180192	K982532	000
10884521180185	K982532	000
10884521180161	K982532	000
10884521180062	K982532	000
10884521180024	K982532	000
10884521180017	K982532	000
10884521180000	K982532	000
10884521177611	K982532	000
10884521180260	K982532	000
10884521180345	K982532	000
10884521180352	K982532	000
10884521180277	K982532	000
10884521180369	K982532	000
10884521180307	K982532	000
10884521180116	K982532	000
10884521180109	K982532	000
10884521179950	K982532	000
10884521177574	K982532	000
10884521180314	K982532	000
10884521180284	K982532	000
10884521180253	K982532	000
10884521180239	K982532	000
10884521180215	K982532	000
10884521180130	K982532	000
10884521180093	K982532	000
10884521180048	K982532	000
10884521179967	K982532	000
10884521177604	K982532	000