The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Bio-oss.
Device ID | K952617 |
510k Number | K952617 |
Device Name: | BIO-OSS |
Classification | Bone Grafting Material, Synthetic |
Applicant | GEISTLICH-PHARMA ARENT, FOX, KINTNER, PLOTKIN & 1050 CONNECTICUT AVENUE Washington, DC 20003 -6 |
Contact | Peter S Reichertz |
Correspondent | Peter S Reichertz GEISTLICH-PHARMA ARENT, FOX, KINTNER, PLOTKIN & 1050 CONNECTICUT AVENUE Washington, DC 20003 -6 |
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 | 1995-08-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIO-OSS 73806736 1634740 Live/Registered |
ED. GEISTLICH SOHNE AG 1989-06-15 |
BIO-OSS 73525720 1373366 Live/Registered |
ED. GEISTLICH SOHNE AG FUR CHEMISCHE INDUSTRIE 1985-03-07 |