510(k) K892442
K892442 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL CURITY URETHRAL CATHETERS". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. The Kendal Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1989
- Date Received
- April 10, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type