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510(k) K101320

VASOVAPOR by Lexion Medical, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2010
Date Received
May 11, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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  • K120640 — INSUFLOW SYNERGY PORT (July 18, 2012)
  • K112357 — VESSEL GUARDIAN (November 10, 2011)
  • K102136 — VESSEL GUARDIAN (September 27, 2010)
  • K091366 — INSUFLOW DEWHEART (September 3, 2009)
  • K090456 — INSUFLOW (August 26, 2009)

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