510(k) K832107

LEG BAG EXTENTION TUBE-STERILE by Plasco, Inc. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type