510(k) K960486

KSEA MODEL 383320 20 ANGIOMAT by Karl Storz Endoscopy — Product Code DQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1996
Date Received
February 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type