510(k) K940775

INJECTION CAP by Medron, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1994
Date Received
February 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type