The following data is part of a premarket notification filed by Endovations with the FDA for Enteron Percutan. Endoscopic Gastrostomy Tray-peg.
| Device ID | K873360 |
| 510k Number | K873360 |
| Device Name: | ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Susan P Bjorkman |
| Correspondent | Susan P Bjorkman ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-21 |
| Decision Date | 1988-03-30 |