FDA 510(k) Application Details - K070886

Device Classification Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable

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510(K) Number K070886
Device Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant MEDTRONIC INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE, FL 32259 US
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Contact JAYME WILSON
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Regulation Number 874.3620

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Classification Product Code NHB
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Date Received 03/30/2007
Decision Date 04/26/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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