510(k) K101458

LINA XCISE MODEL MOR-1515 by Lina Medical Aps — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2011
Date Received
May 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type