The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Biodesign Nipple Reconstruction Cylinder.
| Device ID | K110402 |
| 510k Number | K110402 |
| Device Name: | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Perry W Guinn |
| Correspondent | Perry W Guinn COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002525498 | K110402 | 000 |
| 00827002491274 | K110402 | 000 |
| 00827002491267 | K110402 | 000 |
| 00827002347908 | K110402 | 000 |
| 00827002347892 | K110402 | 000 |