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 Illuminator, Fiberoptic, Surgical Field
510(k) Number K111342
Device Name LIGHT GUIDE CABLE
Applicant
SCHOTT NORTH AMERICA
40 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact JEFFREY ROBERTS
Correspondent
SCHOTT NORTH AMERICA
40 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact JEFFREY ROBERTS
Regulation Number878.4580
Classification Product Code
HBI  
Date Received05/13/2011
Decision Date 11/25/2011
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
-
-