The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett X-ray Profile Positioning Paddle For Mammography.
| Device ID | K945962 |
| 510k Number | K945962 |
| Device Name: | BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY |
| Classification | System, X-ray, Mammographic |
| 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 | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-07 |
| Decision Date | 1995-04-03 |