The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Guided Tissue Regeneration Matrix.
| Device ID | K010952 |
| 510k Number | K010952 |
| Device Name: | SURGISIS GUIDED TISSUE REGENERATION MATRIX |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Contact | Mark Bleyer |
| Correspondent | Mark Bleyer COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-30 |
| Decision Date | 2002-06-10 |