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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K130497
Device Name D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
Applicant
Linvatec Corporation D/B/A Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact JONATHAN WERNER
Correspondent
Linvatec Corporation D/B/A Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact JONATHAN WERNER
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Codes
ERL   GEY  
Date Received02/26/2013
Decision Date 03/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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