510(k) K896695
K896695 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "DYNA-FLO URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on May 2, 1990. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I 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
- May 2, 1990
- Date Received
- November 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type