510(k) K892069

EXTENDED COVERS, STERILE by Amedic USA — Product Code FFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1989
Date Received
March 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Biopsy Forceps
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type