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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K920091
Device Name IOWA ORAL PERFORMANCE ISNTRUMENT
Applicant
Breakthrough, Inc.
131 Technology Innovation Cent
Oakdale,  IA  52319
Applicant Contact CAROLYN J BROWN
Correspondent
Breakthrough, Inc.
131 Technology Innovation Cent
Oakdale,  IA  52319
Correspondent Contact CAROLYN J BROWN
Regulation Number890.1615
Classification Product Code
IKE  
Date Received01/08/1992
Decision Date 05/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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