510(k) K051281

THE NEEDLE CATCHER by E.D.Medical , Ltd. — Product Code HTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2005
Date Received
May 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type