510(k) K791098
K791098 is an FDA 510(k) premarket notification submitted by Med General for the device "SINGLE-USE MINI-BULLDOG". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Med General has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1979
- Date Received
- June 12, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type