510(k) K791674
K791674 is an FDA 510(k) premarket notification submitted by Latex Ind., Inc. for the device "BLADDER RETENTION CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent on November 5, 1979. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Latex Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1979
- Date Received
- August 27, 1979
- 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