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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Syringe, Restorative And Impression Material
510(k) Number K853282
Device Name CENTRIX RIBBON TUBES
Applicant
Centrix, Inc.
724 Honeyspot Rd.
Stratford,  CT  06497
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
724 Honeyspot Rd.
Stratford,  CT  06497
Correspondent Contact JOHN DISCKO
Regulation Number872.4565
Classification Product Code
EID  
Date Received08/05/1985
Decision Date 08/23/1985
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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