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FDA 510(k) Applications Submitted by ANDREA L RUTH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K051213
05/12/2005
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
ABBOTT LABORATORIES INC
K030342
02/03/2003
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
LUMENIS, LTD.
K040270
02/05/2004
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
LUMENIS LTD.
K030527
02/19/2003
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
LUMENIS
K010956
03/30/2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X
BOSTON SCIENTIFIC CORP.
K022067
06/25/2002
CONVOY ADVANCED DELIVERY SHEATH
BOSTON SCIENTIFIC
K023291
10/02/2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
BOSTON SCIENTIFIC CORP.
K013349
10/09/2001
ASTRONOMER PLUS SYSTEM
EP TECHNOLOGIES, INC.
K013866
11/21/2001
CONVOY ADVANCED DELIVERY SHEATH KIT
BOSTON SCIENTIFIC
K013873
11/21/2001
COBRA CARDIAC ELECTROSURGICAL SYSTEM
BOSTON SCIENTIFIC CORP.
K181472
06/04/2018
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
Advanced Sterilization Products (ASP)
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