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FDA 510(k) Application Details - K110636
Device Classification Name
Device, Iontophoresis, Other Uses
More FDA Info for this Device
510(K) Number
K110636
Device Name
Device, Iontophoresis, Other Uses
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact
GURVINDER SINGH NANDA
Other 510(k) Applications for this Contact
Regulation Number
890.5525
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Classification Product Code
EGJ
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More FDA Info for this Product Code
Date Received
03/04/2011
Decision Date
06/16/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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