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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 K940260
Device Name THERMAL PULP TESTER
Applicant
Union Broach, Div. Moyco Industries, Inc.
2054 W. Clearfield St.
Philadelphia,  PA  19132
Applicant Contact CHRIS W LEHR
Correspondent
Union Broach, Div. Moyco Industries, Inc.
2054 W. Clearfield St.
Philadelphia,  PA  19132
Correspondent Contact CHRIS W LEHR
Regulation Number872.1720
Classification Product Code
EAT  
Date Received01/21/1994
Decision Date 03/07/1994
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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