510(k) K972887
K972887 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG". The FDA issued a decision of Substantially Equivalent on December 11, 1997. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1997
- Date Received
- August 5, 1997
- 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