The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Gastrostomy Tube.
| Device ID | K931921 | 
| 510k Number | K931921 | 
| Device Name: | CORPAK GASTROSTOMY TUBE | 
| Classification | Tubes, Gastrointestinal (and Accessories) | 
| Applicant | CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 | 
| Contact | Robert E Booth | 
| Correspondent | Robert E Booth 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 | 1993-04-16 | 
| Decision Date | 1995-06-09 |