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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 K895508
Device Name CALASEPT PASTE
Applicant
Js Dental Mfg., Inc.
P.O. Box 904
Ridgefield,  CT  06877
Applicant Contact ABRAHAM WOHL
Correspondent
Js Dental Mfg., Inc.
P.O. Box 904
Ridgefield,  CT  06877
Correspondent Contact ABRAHAM WOHL
Regulation Number872.3250
Classification Product Code
EJK  
Date Received09/11/1989
Decision Date 12/08/1989
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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