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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K171713
Device Name Neodent Instrument Kits
Applicant
JJGC Industria e Comercio de Materiais Dentarios S.A.
Av. Juscelino Kubitschek de Oliveira, 3291 – CIC
Curitiba,  BR 81270-200
Applicant Contact Julianne de Oliveira Capucho Lechechem
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/09/2017
Decision Date 04/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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