Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name operating room accessories table tray
510(k) Number K790674
Device Name THE SURGICAL ASSISTANT
Applicant
INSTRUMENT MAKAR, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSTRUMENT MAKAR, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received04/09/1979
Decision Date 05/14/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-