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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K865082
Device Name PROPHY CARE SOLUTION
Applicant
Imd, Inc.
P.O. Box 159
509 Commerce St.
Franklin Lakes,  NJ  07417
Applicant Contact MICHAEL FELDMAN
Correspondent
Imd, Inc.
P.O. Box 159
509 Commerce St.
Franklin Lakes,  NJ  07417
Correspondent Contact MICHAEL FELDMAN
Regulation Number872.6030
Classification Product Code
EJR  
Date Received12/30/1986
Decision Date 02/12/1987
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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