510(k) K781433
K781433 is an FDA 510(k) premarket notification submitted by Latex Ind., Inc. for the device "AKRON MALE EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on November 3, 1978. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Latex Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1978
- Date Received
- August 21, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type