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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K073276
Device Name IONTOPHORESIS SYSTEM
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 Number890.5525
Classification Product Code
EGJ  
Date Received11/21/2007
Decision Date 03/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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