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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Manual)
510(k) Number K153587
Device Name Taps for Resorbable Screws
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Susan Lewandowski
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Susan Lewandowski
Regulation Number882.4300
Classification Product Code
HBG  
Date Received12/16/2015
Decision Date 01/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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