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FDA 510(k) Application Details - K981966
Device Classification Name
Balloon, Epistaxis
More FDA Info for this Device
510(K) Number
K981966
Device Name
Balloon, Epistaxis
Applicant
MICHAEL M. KNOTT, M.D.
355 ROSE PINE COURT
PO BOX 5577
TAHOE CITY, CA 96145-5577 US
Other 510(k) Applications for this Company
Contact
MICHAEL M KNOTT
Other 510(k) Applications for this Contact
Regulation Number
874.4100
More FDA Info for this Regulation Number
Classification Product Code
EMX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/1998
Decision Date
08/14/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K981966
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