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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 K022906
Device Name RESQPOD CIRCULATORY ENHANCER
Applicant
Cprx, LLC
7615 Golden Triangle Dr.,
Suite A
Eden Prairie,  MN  55344
Applicant Contact JOHN F STAPLETON
Correspondent
Cprx, LLC
7615 Golden Triangle Dr.,
Suite A
Eden Prairie,  MN  55344
Correspondent Contact JOHN F STAPLETON
Regulation Number868.5690
Classification Product Code
BWF  
Subsequent Product Code
JOW  
Date Received09/03/2002
Decision Date 06/11/2003
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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