FDA 510(k) Application Details - K092590

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

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510(K) Number K092590
Device Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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Contact LESLIE YOUNG
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Regulation Number 874.3620

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Classification Product Code NHB
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Date Received 08/24/2009
Decision Date 02/17/2010
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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