The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Replacement Gastrostomy Device Stomacore.
| Device ID | K935512 |
| 510k Number | K935512 |
| Device Name: | CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Erik Andersen |
| Correspondent | Erik Andersen CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1996-08-29 |