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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K150830
Device Name CompleClear Plastic Orthodontic Bracket and Wire Appliance
Applicant
Oracrew
210 E Flamingo Rd. #217
Las Vegas,  NV  89169
Applicant Contact PAWAN GAUTAM
Correspondent
Blackwell Device Consulting
P.O. Box 5845
Statesville,  NC  28687
Correspondent Contact ANGELA BLACKWELL
Regulation Number872.5470
Classification Product Code
DYW  
Subsequent Product Code
DZC  
Date Received03/30/2015
Decision Date 08/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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