BIOPLUS

Filler, Bone Void, Calcium Compound

BERKELEY ADVANCED BIOMATERIALS, INC.

The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for Bioplus.

Pre-market Notification Details

• Device ID: K042636
• 510k Number: K042636
• Device Name: BIOPLUS
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: BERKELEY ADVANCED BIOMATERIALS, INC. 1933 DAVIS ST. SUITE 307 San Leandro, CA 94577
• Contact: Francois Genin
• Correspondent: Francois Genin; BERKELEY ADVANCED BIOMATERIALS, INC. 1933 DAVIS ST. SUITE 307 San Leandro, CA 94577
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-27
• Decision Date: 2004-12-14
• Summary: summary