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FDA 510(k) Application Details - K013266
Device Classification Name
Prosthesis, Tracheal, Expandable, Polymeric
More FDA Info for this Device
510(K) Number
K013266
Device Name
Prosthesis, Tracheal, Expandable, Polymeric
Applicant
RUSCH INTL.
50 PLANTATION DR.
JAFFERY, NH 03452 US
Other 510(k) Applications for this Company
Contact
KARENANN J BROZOWSKI
Other 510(k) Applications for this Contact
Regulation Number
878.3720
More FDA Info for this Regulation Number
Classification Product Code
NYT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2001
Decision Date
11/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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