510(k) K850285
K850285 is an FDA 510(k) premarket notification submitted by Premium Plastics, Inc. for the device "GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent on February 28, 1985. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Premium Plastics, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1985
- Date Received
- January 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type