The following data is part of a premarket notification filed by Cook Biotech Incorprated with the FDA for Sis Inguinal Hernia Repair Graft.
| Device ID | K142887 |
| 510k Number | K142887 |
| Device Name: | SIS Inguinal Hernia Repair Graft |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Perry W Guinn |
| Correspondent | Katrina Molland, Ph.d., Ras COOK BIOTECH INCORPRATED 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 | 2014-10-02 |
| Decision Date | 2015-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002447790 | K142887 | 000 |
| 00827002447783 | K142887 | 000 |
| 00827002447776 | K142887 | 000 |
| 10827002314525 | K142887 | 000 |
| 10827002314518 | K142887 | 000 |
| 10827002311418 | K142887 | 000 |