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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 K932298
Device Name PRO'S NEO-LASTICS
Applicant
Professional Positioners, Inc.
2525 Three Mile Rd.
Racine,  WI  53404
Applicant Contact SANDRA IVANOSKI
Correspondent
Professional Positioners, Inc.
2525 Three Mile Rd.
Racine,  WI  53404
Correspondent Contact SANDRA IVANOSKI
Regulation Number872.5410
Classification Product Code
ECI  
Date Received05/11/1993
Decision Date 02/14/1994
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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