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510(k) K092897

LAP LOOP by Medsys, S.A. — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2010
Date Received
September 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by Medsys, S.A.

  • K062968 — LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES (January 3, 2007)
  • K023735 — LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 (August 7, 2003)
  • K971229 — CAPNOXYGEN MASK (September 23, 1997)

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  • K132135 — LINA GOLD LOOP HC (January 31, 2014)
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