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FDA 510(k) Application Details - K972258
Device Classification Name
Catheters, Suction, Tracheobronchial
More FDA Info for this Device
510(K) Number
K972258
Device Name
Catheters, Suction, Tracheobronchial
Applicant
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS, MO 63134 US
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Contact
MICHAEL B SCHOECK
Other 510(k) Applications for this Contact
Regulation Number
868.6810
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Classification Product Code
BSY
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More FDA Info for this Product Code
Date Received
06/17/1997
Decision Date
12/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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