The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett Mammography Positioning Chair Model No. M-pch.
Device ID | K940701 |
510k Number | K940701 |
Device Name: | BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH |
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 | 1994-02-16 |
Decision Date | 1994-04-28 |