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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K842994
Device Name EMA FREEGENOL DENTAL CEMENT
Applicant
Int'L Corp.
7830 E. Redfield Rd.
Suite 12
Scottsdale,  AZ  82560
Applicant Contact DONALD MCKENZIE
Correspondent
Int'L Corp.
7830 E. Redfield Rd.
Suite 12
Scottsdale,  AZ  82560
Correspondent Contact DONALD MCKENZIE
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/30/1984
Decision Date 10/18/1984
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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