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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K933507
Device Name NEEDLETUBE SYRINGE CARTRTIDGE
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Correspondent Contact JOHN DISCKO
Regulation Number872.3250
Classification Product Code
EJK  
Date Received07/15/1993
Decision Date 01/18/1994
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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