510(k) K941743

CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP by Cabot Medical Corp. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1995
Date Received
April 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type