FDA 510(k) Applications Submitted by BOB PIENKOWSKI

FDA 510(k) Number Submission Date Device Name Applicant
K010116 01/16/2001 PLANMED SOPHIE, PLANMED SOPHIE CLASSIC PLANMED OY
K000454 02/11/2000 DIMEX 2 PLANMECA OY
K000771 03/09/2000 DIMAX 2 PLANMECA OY
K091197 04/23/2009 PLANMECA PROSENSOR PLANMECA OY
K111361 05/16/2011 PLANMED NUANCE EXCEL PLANMECA USA, INC.
K011619 05/25/2001 PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT PLANMECA OY
K991826 05/28/1999 PLANMED SOPHIE AND SOPHIE CLASSIC PLANMED OY
K051464 06/03/2005 PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) PLANMECA OY
K021945 06/13/2002 PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) PLANMED OY
K081699 06/17/2008 PLANMECA SOVEREIGN PLANMECA USA, INC.
K973493 09/15/1997 PLANMED CYTOGUIDE PLANMED OY
K042671 09/29/2004 PLANMED SOPHIE NUANCE CLASSIC PLANMED OY
K013656 11/06/2001 PLANMED SOPHIE & PLANMED SOPHIE CLASSIC PLANMED OY


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