510(k) K821168

DISPOSABLE URINARY LEGBAG W/STRAP by Medical Marketing Group — Product Code KNX

K821168 is an FDA 510(k) premarket notification submitted by Medical Marketing Group for the device "DISPOSABLE URINARY LEGBAG W/STRAP". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medical Marketing Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
April 27, 1982
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