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FDA 510(k) Application Details - K992256
Device Classification Name
Spirometer, Therapeutic (Incentive)
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510(K) Number
K992256
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
INTERCONTINENTAL NEW TECHNOLOGIES, INC.
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
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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
07/06/1999
Decision Date
01/11/2000
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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