510(k) K974253

CPD COMMANDER by Scieran Technologies, Inc. — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1998
Date Received
November 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Ophthalmic
Device Class
Class II
Regulation Number
880.5725
Review Panel
OP
Submission Type