The following data is part of a premarket notification filed by Endovations with the FDA for Enteron Liver Biopsy Tray.
| Device ID | K874062 |
| 510k Number | K874062 |
| Device Name: | ENTERON LIVER BIOPSY TRAY |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902004766 | K874062 | 000 |