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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K895854
Device Name ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)
Applicant
Acme-Monaco Corp.
P.O. Box 264
Plainville,  CT  06052
Applicant Contact HERBERT M CARTER
Correspondent
Acme-Monaco Corp.
P.O. Box 264
Plainville,  CT  06052
Correspondent Contact HERBERT M CARTER
Regulation Number872.5410
Classification Product Code
EJF  
Date Received10/03/1989
Decision Date 04/09/1990
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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