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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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