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 Microscope, Surgical
510(k) Number K942233
Device Name MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
Applicant
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Applicant Contact CYNTHIA A GIFFORD,RN
Correspondent
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Correspondent Contact CYNTHIA A GIFFORD,RN
Regulation Number878.4700
Classification Product Code
EPT  
Date Received05/09/1994
Decision Date 07/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-