510(k) K884819
K884819 is an FDA 510(k) premarket notification submitted by Medical Marketing Group for the device "O'NEIL URINARY CATHETER INTRODUCER". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code KNY (Accessories, Catheter, G-U), 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
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- November 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Catheter, G-U
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type