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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K970134
Device Name THERMAPREP PLUS OVEN
Applicant
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Applicant Contact RUSSELL VANDERSLICE
Correspondent
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Correspondent Contact RUSSELL VANDERSLICE
Regulation Number872.3850
Classification Product Code
EKM  
Date Received01/15/1997
Decision Date 03/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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