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510(k) K111016

SAFEPORT MANIFOLD (TM) (OR STOPCOCK) by Elcam Medical Acal — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2011
Date Received
April 12, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Elcam Medical Acal

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  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)
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  • K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (June 8, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K100425 — HASKAL TORQUE DEVICE (June 17, 2010)
  • K082106 — ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (October 2, 2008)

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