CARRIGEN

Bone Grafting Material, Synthetic

ETEX CORP.

The following data is part of a premarket notification filed by Etex Corp. with the FDA for Carrigen.

Pre-market Notification Details

• Device ID: K100883
• 510k Number: K100883
• Device Name: CARRIGEN
• Classification: Bone Grafting Material, Synthetic
• Applicant: ETEX CORP. 38 SIDNEY ST. Cambridge, MA 02139
• Contact: Christopher Klaczyk
• Correspondent: Christopher Klaczyk; ETEX CORP. 38 SIDNEY ST. Cambridge, MA 02139
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-30
• Decision Date: 2010-12-21
• Summary: summary