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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K130180
Device Name CLEANSER ROOT CANAL
Applicant
Cerkamed Wojciech Pawlowski
Kwiatkowskiego 1 St.
Stalowa Wola, Podkarpacie,  PL 37-450
Applicant Contact KINGA WIERUCKA
Correspondent
Cerkamed Wojciech Pawlowski
Kwiatkowskiego 1 St.
Stalowa Wola, Podkarpacie,  PL 37-450
Correspondent Contact KINGA WIERUCKA
Classification Product Code
KJJ  
Date Received01/25/2013
Decision Date 10/03/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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