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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 K040084
Device Name LIFESTYLE CIRCULATORY ENHANCER
Applicant
ADVANCED CIRCULATORY SYSTEMS, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
ADVANCED CIRCULATORY SYSTEMS, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number868.5690
Classification Product Code
BWF  
Subsequent Product Codes
DWL   JOW  
Date Received01/15/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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