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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K884652
Device Name OCTYLDENT
Applicant
Crx Medical, Inc.
5265 N. Blvd.
Raleigh,  NC  27604
Applicant Contact CHARLES R DESMET
Correspondent
Crx Medical, Inc.
5265 N. Blvd.
Raleigh,  NC  27604
Correspondent Contact CHARLES R DESMET
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/07/1988
Decision Date 05/24/1989
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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