510(k) K910578

MCLAUGHLIN LAPAROSCOPIC GRASPER by Marlo Surgical Technology — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
February 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type