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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K842634
Device Name PFLEX RESPIRATORY MUSCLE EXERCISER
Applicant
Health Scan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Health Scan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/06/1984
Decision Date 08/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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