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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ear, nose and throat, synthetic, absorbable
510(k) Number K092590
Device Name PDS PLATES
Applicant
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact LESLIE YOUNG
Correspondent
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact LESLIE YOUNG
Regulation Number874.3620
Classification Product Code
NHB  
Date Received08/24/2009
Decision Date 02/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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