510(k) K791372

JELCO & KVO CATHETER PLACEMENT UNIT by Jelco Laboratories — Product Code JCY

K791372 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "JELCO & KVO CATHETER PLACEMENT UNIT". The FDA issued a decision of Substantially Equivalent on September 12, 1979. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Jelco Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1979
Date Received
July 24, 1979
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