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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handle, Instrument, Dental
510(k) Number K922633
Device Name CAVI-ZYME
Applicant
E&D Dental Products, Inc.
560 Springfield Ave.
Suite 1b
Westfield,  NJ  07090
Applicant Contact ED SPEHAR
Correspondent
E&D Dental Products, Inc.
560 Springfield Ave.
Suite 1b
Westfield,  NJ  07090
Correspondent Contact ED SPEHAR
Regulation Number872.4565
Classification Product Code
EJB  
Date Received05/20/1992
Decision Date 08/06/1992
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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