BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY

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 Bi-ostetic Foam And Putty, Generos Foam And Putty.

Pre-market Notification Details

• Device ID: K092046
• 510k Number: K092046
• Device Name: BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: BERKELEY ADVANCED BIOMATERIALS, INC. 901 GRAYSON ST., SUITE 101 Berkeley, CA 94710
• Contact: Francois Genin
• Correspondent: Francois Genin; BERKELEY ADVANCED BIOMATERIALS, INC. 901 GRAYSON ST., SUITE 101 Berkeley, CA 94710
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-06
• Decision Date: 2010-03-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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