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FDA 510(k) Application Details - K033401
Device Classification Name
Spirometer, Therapeutic (Incentive)
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510(K) Number
K033401
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
ADVANCED CIRCULATORY SYSTEMS, INC.
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact
Gary Syring
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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
10/24/2003
Decision Date
11/20/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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