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 Light, Surgical, Fiberoptic
510(k) Number K200874
Device Name TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
Applicant
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Applicant Contact Marshall McCarty
Correspondent
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact Marshall McCarty
Regulation Number878.4580
Classification Product Code
FST  
Date Received04/01/2020
Decision Date 06/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-