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FDA 510(k) Application Details - K964369
Device Classification Name
Catheters, Suction, Tracheobronchial
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510(K) Number
K964369
Device Name
Catheters, Suction, Tracheobronchial
Applicant
BALLARD MEDICAL PRODUCTS
12050 LONE PEAK PKWY.
DRAPER, UT 84020 US
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Contact
E. MARTIN CHAMBERLAIN, JR.
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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
11/01/1996
Decision Date
02/11/1997
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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