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FDA 510(k) Application Details - K962133
Device Classification Name
Balloon, Epistaxis
More FDA Info for this Device
510(K) Number
K962133
Device Name
Balloon, Epistaxis
Applicant
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 SOUTH REVERE PARKWAY,
SUITE 60
ENGLEWOOD, CO 80112 US
Other 510(k) Applications for this Company
Contact
SARAH M LAKE
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
06/03/1996
Decision Date
08/01/1996
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
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