510(k) K900016

TRANS/R - FP(3) by CIVCO Medical Instruments Co., Inc. — Product Code FCY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 11, 1990
Date Received: January 2, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bulb, Inflation, For Endoscope
Device Class: Class I
Regulation Number: 876.1500
Review Panel: GU
Submission Type

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

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510(k) K900016

Clearance Details

Device Classification

Other clearances by CIVCO Medical Instruments Co., Inc.

Other clearances for product code FCY