510(k) K905722

SUTURE APPLIER DEVICE by Laparomed Corp. — Product Code MFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1991
Date Received
December 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Endoscopic Suturing
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type