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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K932761
Device Name SOFT-WEAR HEADGEAR AND SAFETY MODULES
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 Number872.5500
Classification Product Code
DZB  
Date Received06/08/1993
Decision Date 10/07/1993
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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