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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pulp
510(k) Number K870118
Device Name MODEL 6110B DENTAPHOR
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236 -6221
Applicant Contact COATS, M.D.
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236 -6221
Correspondent Contact COATS, M.D.
Regulation Number872.1720
Classification Product Code
EAT  
Date Received01/12/1987
Decision Date 04/10/1987
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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