510(k) K813606

SILICONE ELASTOMER INFUSION CATHETER by Quest Medical, Inc. — Product Code JCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1982
Date Received
December 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Infusion
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type