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510(k) K231900

A-TAP (previously called Arthrotap) by Elcam Medical Acal — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2023
Date Received
June 28, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
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)
  • K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (July 16, 2012)
  • K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (June 8, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (June 9, 2011)
  • K100425 — HASKAL TORQUE DEVICE (June 17, 2010)
  • K082106 — ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (October 2, 2008)

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