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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Band, Elastic, Orthodontic
510(k) Number K930453
Device Name SINGLES
Applicant
Nexadental
4014 S. 108th St.
Omaha,  NE  68137
Applicant Contact CLIFFORD L HERD
Correspondent
Nexadental
4014 S. 108th St.
Omaha,  NE  68137
Correspondent Contact CLIFFORD L HERD
Regulation Number872.5410
Classification Product Code
ECI  
Date Received01/27/1993
Decision Date 05/27/1993
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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