The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Gastrostomy Tube.
| Device ID | K901501 |
| 510k Number | K901501 |
| Device Name: | CORPAK GASTROSTOMY TUBE |
| Classification | Tube, Gastro-enterostomy |
| 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 | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-30 |
| Decision Date | 1990-06-11 |