The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Bio-oss Collagen.
Device ID | K974399 |
510k Number | K974399 |
Device Name: | BIO-OSS COLLAGEN |
Classification | Bone Grafting Material, Synthetic |
Applicant | GEISTLICH-PHARMA WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
Contact | Peter S Reichertz |
Correspondent | Peter S Reichertz GEISTLICH-PHARMA WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, 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 | 1997-11-21 |
Decision Date | 1998-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIO-OSS COLLAGEN 75413465 2300656 Live/Registered |
EDWARD GEISTLICH SOHNE AG FUR CHEMISCHE 1997-12-31 |