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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Retentive And Splinting, And Accessory Instruments
510(k) Number K924376
Device Name ROOT CANAL POST
Applicant
The Thera Group
7-B Old Colony Dr.
Westford,  MA  01886
Applicant Contact JAMES R MARSHALL
Correspondent
The Thera Group
7-B Old Colony Dr.
Westford,  MA  01886
Correspondent Contact JAMES R MARSHALL
Regulation Number872.3740
Classification Product Code
EBL  
Subsequent Product Code
ELB  
Date Received08/28/1992
Decision Date 11/22/1993
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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