Home / 510(k) Clearances / K940780

510(k) K940780

SCOPEJOCKEY by Fibertech Instruments, Inc. — Product Code OCU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 10, 1994
Date Received: February 22, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Endoscopic Storage Cover
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.