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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K911208
Device Name TIN COATED DENTAL BURS
Applicant
Surgical Precision Instruments, Corp.
64 Chapman Dr.
Barrington,  NH  03825
Applicant Contact LARRY ROGERS
Correspondent
Surgical Precision Instruments, Corp.
64 Chapman Dr.
Barrington,  NH  03825
Correspondent Contact LARRY ROGERS
Regulation Number872.3240
Classification Product Code
EJL  
Date Received03/19/1991
Decision Date 09/16/1991
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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