The following data is part of a premarket notification filed by Cook Biotech Incorprated with the FDA for Biodesign Ent Repair Graft.
| Device ID | K121360 |
| 510k Number | K121360 |
| Device Name: | BIODESIGN ENT REPAIR GRAFT |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Mary A Faderan, Ph.d., Rac |
| Correspondent | Mary A Faderan, Ph.d., Rac COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2013-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002359505 | K121360 | 000 |
| 00827002359499 | K121360 | 000 |
| 00827002359482 | K121360 | 000 |
| 00827002359475 | K121360 | 000 |