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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 K974848
Device Name MINI-CISER
Applicant
HOUGEN MFG., INC.
3001 HOUGEN DR.
SWARTZ CREEK,  MI  48473
Applicant Contact JEFFERY R MILLER
Correspondent
HOUGEN MFG., INC.
3001 HOUGEN DR.
SWARTZ CREEK,  MI  48473
Correspondent Contact JEFFERY R MILLER
Regulation Number868.5690
Classification Product Code
BWF  
Date Received12/29/1997
Decision Date 08/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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