The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Percutaneous Endoscopic Gastrostomy Tube.
| Device ID | K882867 |
| 510k Number | K882867 |
| Device Name: | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Robert B Edwards |
| Correspondent | Robert B Edwards 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 | 1988-07-11 |
| Decision Date | 1988-09-21 |