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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 K952855
Device Name PC-LOCK
Applicant
Midwest Orthodontic Mfg.
4570 Progress Dr.
Columbus,  IN  47201
Applicant Contact JEFFREY L FASNACHT
Correspondent
Midwest Orthodontic Mfg.
4570 Progress Dr.
Columbus,  IN  47201
Correspondent Contact JEFFREY L FASNACHT
Regulation Number872.3750
Classification Product Code
DYH  
Date Received06/22/1995
Decision Date 09/08/1995
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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