SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX

Mesh, Surgical, Polymeric

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Sepramesh Biosurgical Composite, Model Smbc-xxx.

Pre-market Notification Details

• Device ID: K994328
• 510k Number: K994328
• Device Name: SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
• Classification: Mesh, Surgical, Polymeric
• Applicant: GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562
• Contact: John A Delucia
• Correspondent: John A Delucia; GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-22
• Decision Date: 2000-03-02
• Summary: summary