The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for The Surgical Assistant.
Device ID | K790674 |
510k Number | K790674 |
Device Name: | THE SURGICAL ASSISTANT |
Classification | Operating Room Accessories Table Tray |
Applicant | INSTRUMENT MAKAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-09 |
Decision Date | 1979-05-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THE SURGICAL ASSISTANT 85496672 4281629 Live/Registered |
Association of Surgical Technologists, Inc. 2011-12-15 |