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510(k) K922145

SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS by Atos Medical AB — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1993
Date Received
May 7, 1992
Clearance Type
Traditional
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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  • K060974 — RELIENT NAVIGATION DEVICE (May 5, 2006)
  • K050340 — MICROMEDICS SPHENOID SINUS STENT (April 27, 2005)
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