510(k) K896727

4 SURE URINARY DRAIN BAG by The Boston & Pacific Co., Inc. — Product Code KNX

K896727 is an FDA 510(k) premarket notification submitted by The Boston & Pacific Co., Inc. for the device "4 SURE URINARY DRAIN BAG". The FDA issued a decision of Substantially Equivalent on February 20, 1990. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. The Boston & Pacific Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1990
Date Received
November 29, 1989
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