The following data is part of a premarket notification filed by Absolute X-ray Corp. with the FDA for Mammographic Model Cxr 51 Mo-6'/0.6 Sh.
Device ID | K864042 |
510k Number | K864042 |
Device Name: | MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH |
Classification | Assembly, Tube Housing, X-ray, Diagnostic |
Applicant | ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City, NY 11106 |
Contact | George S Pavel |
Correspondent | George S Pavel ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City, NY 11106 |
Product Code | ITY |
CFR Regulation Number | 892.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-16 |
Decision Date | 1986-10-27 |