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 K080367
Device Name ZIMMER MIS LIGHT
Applicant
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Applicant Contact ELSA A LINKE
Correspondent
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Correspondent Contact ELSA A LINKE
Regulation Number878.4580
Classification Product Code
FST  
Date Received02/12/2008
Decision Date 02/22/2008
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
-
-