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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K070246
Device Name DOWN PAK
Applicant
Endo Twinn B.V.
Danzigerkade 17
Amsterdam,  NL 1013 AP
Applicant Contact F.M. VERHOEVEN
Correspondent
Endo Twinn B.V.
Danzigerkade 17
Amsterdam,  NL 1013 AP
Correspondent Contact F.M. VERHOEVEN
Regulation Number872.3850
Classification Product Code
EKM  
Date Received01/25/2007
Decision Date 02/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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