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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 K033401
Device Name MODIFICATION TO RESQPOD 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 Code
JOW  
Date Received10/24/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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