510(k) K790478
K790478 is an FDA 510(k) premarket notification submitted by Browne Corp. for the device "BROWNE MODEL UD-4DE". The FDA issued a decision of Substantially Equivalent on Jun 1, 1979. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Browne Corp. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 1979
- Date Received
- Mar 9, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device Class
- Class II
- Regulation Number
- 876.1620
- Review Panel
- GU
- Submission Type
- 510(k) Exempt