The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set.
| Device ID | K182832 |
| 510k Number | K182832 |
| Device Name: | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set |
| Classification | Tube, Gastro-enterostomy |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Kotei Aoki |
| Correspondent | Rohini Patel Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2019-06-26 |