The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Durasis Dural Substitute.
| Device ID | K031850 |
| 510k Number | K031850 |
| Device Name: | DURASIS DURAL SUBSTITUTE |
| Classification | Dura Substitute |
| 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 | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002324371 | K031850 | 000 |
| 10827002310923 | K031850 | 000 |
| 10827002310916 | K031850 | 000 |
| 10827002310909 | K031850 | 000 |
| 00827002324374 | K031850 | 000 |
| 00827002310926 | K031850 | 000 |
| 00827002310919 | K031850 | 000 |
| 00827002310902 | K031850 | 000 |