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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rongeur, manual
510(k) Number K130541
Device Name SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
Applicant
SYMMETRY SURGICAL
1927 N. ARTHUR DR.
COLUMBIA CITY,  IN  46725
Applicant Contact DALENE BINKLEY
Correspondent
SYMMETRY SURGICAL
1927 N. ARTHUR DR.
COLUMBIA CITY,  IN  46725
Correspondent Contact DALENE BINKLEY
Regulation Number882.4840
Classification Product Code
HAE  
Date Received03/01/2013
Decision Date 08/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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