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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K103346
Device Name DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
Applicant
Sherpa Korea
56b Shadowbrook Dr.
Hudson,  NH  03051
Applicant Contact RAYMOND KELLY
Correspondent
Sherpa Korea
56b Shadowbrook Dr.
Hudson,  NH  03051
Correspondent Contact RAYMOND KELLY
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/15/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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