The following data is part of a premarket notification filed by Thermotrex Corp. with the FDA for High Transmission Cellular (htc) Grids 18x24 Cm & 24x30 Cm Sizes.
| Device ID | K954294 |
| 510k Number | K954294 |
| Device Name: | HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES |
| Classification | Grid, Radiographic |
| Applicant | THERMOTREX CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Jeffrey Moeller |
| Correspondent | Jeffrey Moeller THERMOTREX CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Product Code | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1996-02-02 |