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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K880562
Device Name ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
Applicant
Macrochem Corp.
21x Olympia Ave.
Woburn,  MA  01801
Applicant Contact CARLOS M SAMOUR,PHD
Correspondent
Macrochem Corp.
21x Olympia Ave.
Woburn,  MA  01801
Correspondent Contact CARLOS M SAMOUR,PHD
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/11/1988
Decision Date 08/19/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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