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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
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