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, Ceiling Mounted
510(k) Number K140461
Device Name MACH LED 2MC
Applicant
Dr. Mach GmbH & Co. KG
Fehmarnstrasse 31
Norderstedt, Schleswig-Holstein,  DE 22846
Applicant Contact GUDRUN BUSCH, PH.D.
Correspondent
Dr. Mach GmbH & Co. KG
Fehmarnstrasse 31
Norderstedt, Schleswig-Holstein,  DE 22846
Correspondent Contact GUDRUN BUSCH, PH.D.
Regulation Number878.4580
Classification Product Code
FSY  
Date Received02/24/2014
Decision Date 04/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-