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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 K072891
Device Name SINUS SPACER
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact KERI YEN
Correspondent
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact KERI YEN
Regulation Number878.4800
Classification Product Code
KAM  
Date Received10/10/2007
Decision Date 03/19/2008
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
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