510(k) K051860

FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 by Epimed International, Inc. — Product Code MIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Spinal, Short Term
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type