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 |