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FDA 510(k) Application Details - K022906
Device Classification Name
Spirometer, Therapeutic (Incentive)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.5690
More FDA Info for this Regulation Number
Classification Product Code
BWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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