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FDA 510(k) Application Details - K961507
Device Classification Name
Prosthesis, Tracheal, Expandable
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510(K) Number
K961507
Device Name
Prosthesis, Tracheal, Expandable
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS, MN 55442 US
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Contact
CATHY YOHNK
Other 510(k) Applications for this Contact
Regulation Number
878.3720
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Classification Product Code
JCT
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More FDA Info for this Product Code
Date Received
04/19/1996
Decision Date
07/10/1996
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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