The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Sis Facial Cylinder, Sis Facial Implant.
Device ID | K070738 |
510k Number | K070738 |
Device Name: | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT |
Classification | Mesh, Surgical |
Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
Contact | Mary A Faderan |
Correspondent | Mary A Faderan COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-16 |
Decision Date | 2007-04-05 |