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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Syringe, Periodontic, Endodontic, Irrigating
510(k) Number K792461
Device Name CENTRIX MKIV ENDODONTIC DELIVERY
Applicant
Centrix, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Centrix, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EIC  
Date Received12/03/1979
Decision Date 12/19/1979
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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