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510(k) K032127

HEMEDEX FIXATION DEVICE by Hemedex Incorporated — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2003
Date Received
July 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hemedex Incorporated

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  • K013376 — QFLOW 500 PERFUSION MONITORING SYSTEM (May 8, 2002)

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  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)