510(k) K973273

XOMED T-STENT, FRONTAL SINUS STENT by Xomed, Inc. — Product Code KAM

K973273 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XOMED T-STENT, FRONTAL SINUS STENT". The FDA issued a decision of Substantially Equivalent on September 29, 1997. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
September 2, 1997
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