PREMIUM

Mesh, Surgical, Polymeric

COUSIN BIOTECH S.A.S.

The following data is part of a premarket notification filed by Cousin Biotech S.a.s. with the FDA for Premium.

Pre-market Notification Details

• Device ID: K133889
• 510k Number: K133889
• Device Name: PREMIUM
• Classification: Mesh, Surgical, Polymeric
• Applicant: COUSIN BIOTECH S.A.S. 8 RUE DE L ABBE BONPAIN ALLEE DES ROSES Wervicq-sud, FR 59117
• Contact: Franck Pelletier
• Correspondent: Franck Pelletier; COUSIN BIOTECH S.A.S. 8 RUE DE L ABBE BONPAIN ALLEE DES ROSES Wervicq-sud, FR 59117
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-20
• Decision Date: 2014-09-04
• Summary: summary