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FDA 510(k) Applications Submitted by GENERAL SURGICAL INNOVATIONS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K970201
01/21/1997
GSI CANNULA WITH INTRODUCER
GENERAL SURGICAL INNOVATIONS
K972109
06/05/1997
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
GENERAL SURGICAL INNOVATIONS
K962702
07/12/1996
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
GENERAL SURGICAL INNOVATIONS
K973046
08/15/1997
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK
GENERAL SURGICAL INNOVATIONS
K983318
09/21/1998
FIXATION SYSTEM
GENERAL SURGICAL INNOVATIONS
K961356
04/08/1996
MAMMARY SIZER
GENERAL SURGICAL INNOVATIONS
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