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510(k) K072891

SINUS SPACER by Acclarent, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2008
Date Received
October 10, 2007
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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  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
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