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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K933582
Device Name PROFILE SERIES 29 FILES
Applicant
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Applicant Contact MIKE BRADFORD
Correspondent
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Correspondent Contact MIKE BRADFORD
Regulation Number872.4565
Classification Product Code
EKS  
Date Received07/23/1993
Decision Date 10/20/1993
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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