FDA 510(k) Applications Submitted by LORRAINE CALZETTA

FDA 510(k) Number Submission Date Device Name Applicant
K060752 03/21/2006 ACMI DUR-HL LASER SYSTEMS ACMI CORPORATION
K080844 03/26/2008 G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE GYRUS ACMI, INC.
K100896 03/31/2010 GYRUS ACMI HALO PKS CUTTING FORCEPS GYRUS ACMI, INC.
K111059 04/18/2011 GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) GYRUS ACMI, INC.
K081766 06/20/2008 PKS OMNI INSTRUMENT GYRUS-ACMI L.P.
K092571 08/21/2009 GYRUS ACMI BIOCOAG PROBE GYRUS ACMI, INC.
K092682 09/01/2009 GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS GYRUS ACMI, INC.
K102970 10/06/2010 GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT GYRUS ACMI, INC.
K043251 11/23/2004 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B CANDELA CORP.
K050673 03/15/2005 CANDELA FAMILY OF PULSE DYE LASER SYSTEMS CANDELA CORP.
K030846 03/17/2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K041242 05/11/2004 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K051359 05/24/2005 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY CANDELA CORP.
K033331 10/16/2003 CANDELA CBEAM PULSE DYE LASER SYSTEM CANDELA CORP.
K033461 10/30/2003 CANDELA VBEAM PULSE DYE LASER SYSTEM CANDELA CORP.
K033172 09/30/2003 CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS CANDELA CORP.


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