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510(k) K060974

RELIENT NAVIGATION DEVICE by Acclarent, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2006
Date Received
April 10, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Sinus
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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Other clearances for product code KAM

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  • K083574 — RELIEVA STRATUS MICROFLOW SPACER (January 29, 2009)
  • K072891 — SINUS SPACER (March 19, 2008)
  • K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (March 11, 2008)
  • K071845 — RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (September 28, 2007)
  • K062458 — ETHMOID SINUS SPACER (September 15, 2006)
  • K050340 — MICROMEDICS SPHENOID SINUS STENT (April 27, 2005)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K973273 — XOMED T-STENT, FRONTAL SINUS STENT (September 29, 1997)