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FDA 510(k) Application Details - K982945
Device Classification Name
Catheters, Suction, Tracheobronchial
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510(K) Number
K982945
Device Name
Catheters, Suction, Tracheobronchial
Applicant
SPIRIT MEDICAL SYSTEMS, INC.
16267 WHITESTONE DR.
PARKER, CO 80134 US
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Contact
JEFF SAWYER
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Regulation Number
868.6810
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Classification Product Code
BSY
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Date Received
08/21/1998
Decision Date
09/22/1998
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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