OSFERION

Filler, Bone Void, Calcium Compound

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Osferion.

Pre-market Notification Details

• Device ID: K061499
• 510k Number: K061499
• Device Name: OSFERION
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: OLYMPUS AMERICA, INC. 3500 CORPORATE PKWY. P.O. BOX 610 Center Valley, PA 18034 -0610
• Contact: Laura Storms-tyler
• Correspondent: Laura Storms-tyler; OLYMPUS AMERICA, INC. 3500 CORPORATE PKWY. P.O. BOX 610 Center Valley, PA 18034 -0610
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-31
• Decision Date: 2007-01-26
• Summary: summary