510(k) K982472

GENICON TROCAR by Genicon, LC — Product Code GEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1999
Date Received
July 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type