510(k) K050340

MICROMEDICS SPHENOID SINUS STENT by Micromedics, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2005
Date Received
February 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Sinus
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type