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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Sinus
510(k) Number K083574
Device Name RELIEVA STRATUS MICROFLOW SPACER
Applicant
Acclarent, Inc.
1525-B O'Brien Dr.
Rmenlo Park,  CA  94025
Applicant Contact KERI YEN
Correspondent
Acclarent, Inc.
1525-B O'Brien Dr.
Rmenlo Park,  CA  94025
Correspondent Contact KERI YEN
Regulation Number878.4800
Classification Product Code
KAM  
Date Received12/03/2008
Decision Date 01/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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