The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett X-ray Horiz Radio Float/hi-lo Elev Table.
Device ID | K913243 |
510k Number | K913243 |
Device Name: | BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE |
Classification | Phantom, Anthropomorphic, Radiographic |
Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Contact | Robert P Coe |
Correspondent | Robert P Coe BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Product Code | IXG |
CFR Regulation Number | 892.1950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-22 |
Decision Date | 1991-09-19 |