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FDA 510(k) Application Details - K021901
Device Classification Name
Prosthesis, Tracheal, Expandable
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510(K) Number
K021901
Device Name
Prosthesis, Tracheal, Expandable
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
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Contact
SHERRY L SPARROW
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
06/10/2002
Decision Date
07/09/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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