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510(k) K093594

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER by Acclarent, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2010
Date Received
November 19, 2009
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

  • K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (October 7, 2011)
  • 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)
  • K060974 — RELIENT NAVIGATION DEVICE (May 5, 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)