The following data is part of a premarket notification filed by Ets Rene Marzet with the FDA for Operating Tables & Amplinox 03.
Device ID | K792569 |
510k Number | K792569 |
Device Name: | OPERATING TABLES & AMPLINOX 03 |
Classification | Table And Attachments, Operating-room |
Applicant | ETS RENE MARZET 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BWN |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-13 |
Decision Date | 1980-01-04 |