The following data is part of a premarket notification filed by Cook Biotech Incorprated with the FDA for Biodesign Enterocutaneous Fistula Plug.
| Device ID | K150668 |
| 510k Number | K150668 |
| Device Name: | Biodesign Enterocutaneous Fistula Plug |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Perry W Guinn |
| Correspondent | Nick Wang COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-12-09 |
| Summary: | summary |