The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett Overhead Tube Crane Model No. B-otc.
Device ID | K914944 |
510k Number | K914944 |
Device Name: | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC |
Classification | Tube Mount, X-ray, Diagnostic |
Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Contact | W. F Schneider |
Correspondent | W. F Schneider BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Product Code | IYB |
CFR Regulation Number | 892.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-04 |
Decision Date | 1991-12-02 |