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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 K800138
Device Name TS-301 THREE-WAY PULP TESTER
Applicant
Tamler-Stoneham Instruments
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tamler-Stoneham Instruments
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.1720
Classification Product Code
EAT  
Date Received01/21/1980
Decision Date 02/13/1980
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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