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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 K913974
Device Name ACCESS IMPRESSION BARREL
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
EID  
Date Received09/06/1991
Decision Date 02/25/1992
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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