BIO-OSS

Bone Grafting Material, Synthetic

GEISTLICH-PHARMA

The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Bio-oss.

Pre-market Notification Details

• Device ID: K952618
• 510k Number: K952618
• Device Name: BIO-OSS
• Classification: Bone Grafting Material, Synthetic
• Applicant: GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036
• Contact: Peter S Reichertz
• Correspondent: Peter S Reichertz; GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-06-06
• Decision Date: 1995-08-28