510(k) K760173

BRIDGE, SHORT DEFLECTING by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1976
Date Received
July 6, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sigmoidoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to examine and perform procedures within the sigmoid (descending) colon