510(k) K840324

SILICONE SUMP DRAIN 20 & 40 FRENCH by Superior Plastic Products Corp. — Product Code JCY

K840324 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "SILICONE SUMP DRAIN 20 & 40 FRENCH". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Superior Plastic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
January 25, 1984
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