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FDA 510(k) Application Details - K030917
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K030917
Device Name
Spirometer, Diagnostic
Applicant
COLLINS MEDICAL, INC.
220 WOOD RD.
BRAINTREE, MA 02184-2408 US
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Contact
DONALD HENTON
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/2003
Decision Date
05/14/2003
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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