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510(k) K062458

ETHMOID SINUS SPACER by Acclarent, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2006
Date Received
August 23, 2006
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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