510(k) K910022
K910022 is an FDA 510(k) premarket notification submitted by Medical Marketing Group for the device "MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 2, 1991. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. Medical Marketing Group has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- April 2, 1991
- Date Received
- January 3, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type