The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Entuit Start Initial Placement Gastrostomy Set.
| Device ID | K170323 |
| 510k Number | K170323 |
| Device Name: | Entuit Start Initial Placement Gastrostomy Set |
| Classification | Tube, Gastro-enterostomy |
| Applicant | Cook Incorporated 450 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Erum B. Nasir |
| Correspondent | Erum B. Nasir Cook Incorporated 450 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-01 |
| Decision Date | 2017-09-14 |
| Summary: | summary |