The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Hm-cap Control Panel.
| Device ID | K954926 |
| 510k Number | K954926 |
| Device Name: | HM-CAP CONTROL PANEL |
| Classification | Helicobacter Pylori |
| Applicant | E-Z-EM, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus E-Z-EM, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-26 |
| Decision Date | 1996-01-30 |