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510(k) K961356

MAMMARY SIZER by General Surgical Innovations — Product Code MRD

Clearance Details

Decision
SN ()
Decision Date
September 23, 1996
Date Received
April 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mammary Sizer
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by General Surgical Innovations

  • K983318 — FIXATION SYSTEM (March 1, 1999)
  • K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, (January 16, 1998)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • K970201 — GSI CANNULA WITH INTRODUCER (April 21, 1997)
  • K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION A (February 19, 1997)
  • K952278 — THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA (August 7, 1995)
  • K951878 — SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA (June 29, 1995)
  • K944418 — THE SPACEMAKER AND THE SPACEMAKER II (November 1, 1994)
  • K944536 — GSI KNOTMAKER (October 5, 1994)
  • K943671 — GSI CANNULA REDUCER ACCESSORY (August 9, 1994)

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