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FDA 510(k) Application Details - K153441
Device Classification Name
Spirometer, Therapeutic (Incentive)
More FDA Info for this Device
510(K) Number
K153441
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
Medica Holdings, LLC
5200 Meadows Road, Suite 150
Lake Oswego, OR 97035 US
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Contact
George Reed
Other 510(k) Applications for this Contact
Regulation Number
868.5690
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Classification Product Code
BWF
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More FDA Info for this Product Code
Date Received
11/27/2015
Decision Date
03/25/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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