FDA 510(k) Application Details - K022906

Device Classification Name Spirometer, Therapeutic (Incentive)

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510(K) Number K022906
Device Name Spirometer, Therapeutic (Incentive)
Applicant CPRX LLC
7615 GOLDEN TRIANGLE DR.
SUITE A
EDEN PRAIRIE, MN 55344 US
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Contact JOHN F STAPLETON
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Regulation Number 868.5690

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Classification Product Code BWF
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Date Received 09/03/2002
Decision Date 06/11/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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