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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Zinc Oxide Eugenol
510(k) Number K861681
Device Name DENTIMEDIC DENTAL EMERGENCY KIT
Applicant
Dentimedic
102 Eighth St.
Pocomoke City,  MD  21851
Applicant Contact LEISHEAR, DMD
Correspondent
Dentimedic
102 Eighth St.
Pocomoke City,  MD  21851
Correspondent Contact LEISHEAR, DMD
Regulation Number872.3275
Classification Product Code
EMB  
Date Received05/01/1986
Decision Date 09/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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