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, Accessories
510(k) Number K112133
Device Name OASYS SURGICAL LIGHT CONTROLLER
Applicant
Oasys Healthcare
962 Allegro Lane
Apollo Beach,  FL  33572
Applicant Contact TANYA M O'BRIEN
Correspondent
Oasys Healthcare
962 Allegro Lane
Apollo Beach,  FL  33572
Correspondent Contact TANYA M O'BRIEN
Regulation Number878.4580
Classification Product Code
FTA  
Date Received07/26/2011
Decision Date 03/01/2012
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
-
-