510(k) K812639
K812639 is an FDA 510(k) premarket notification submitted by Frontier Products for the device "UNICUFF". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code DXP (Transducer, Vessel Occlusion), a Class II device regulated under 21 CFR 870.2890. Frontier Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1981
- Date Received
- September 16, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Vessel Occlusion
- Device Class
- Class II
- Regulation Number
- 870.2890
- Review Panel
- CV
- Submission Type