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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K882651
Device Name CENTRIX NEEDLETUBE
Applicant
Centrix, Inc.
30 Stran Rd.
Milford,  CT  06460
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
30 Stran Rd.
Milford,  CT  06460
Correspondent Contact JOHN DISCKO
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received06/27/1988
Decision Date 08/10/1988
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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