The following data is part of a premarket notification filed by Stereotactic Medical Systems, Inc. with the FDA for Ep-100 (series).
| Device ID | K884415 |
| 510k Number | K884415 |
| Device Name: | EP-100 (SERIES) |
| Classification | Tube, Feeding |
| Applicant | STEREOTACTIC MEDICAL SYSTEMS, INC. 2801 SO. 1935 WEST West Valley City, UT 84119 |
| Contact | Glen S Putnam |
| Correspondent | Glen S Putnam STEREOTACTIC MEDICAL SYSTEMS, INC. 2801 SO. 1935 WEST West Valley City, UT 84119 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1989-02-28 |