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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 K911061
Device Name ESPE KETAC-ENDO APLICAP
Applicant
H.A. Opotow Consulting
200 Lake Ave.
Suite 205
Lake Worth,  FL  33460
Applicant Contact HAROLD A OPOTOW
Correspondent
H.A. Opotow Consulting
200 Lake Ave.
Suite 205
Lake Worth,  FL  33460
Correspondent Contact HAROLD A OPOTOW
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/11/1991
Decision Date 01/03/1992
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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