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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 K923999
Device Name ALASTIK NS
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016 -5097
Applicant Contact MARLYN SCHEFF
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016 -5097
Correspondent Contact MARLYN SCHEFF
Regulation Number872.5410
Classification Product Code
ECI  
Date Received08/10/1992
Decision Date 06/24/1993
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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