510(k) K924530

CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI by Cabot Medical Corp. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
September 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type