510(k) K820672
K820672 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "HASSON BUEC-3". The FDA issued a decision of Substantially Equivalent on Jul 30, 1982. The device falls under product code HDP (Elevator, Uterine), a Class II device regulated under 21 CFR 884.4530. Bivona Medical Technologies has 49 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 1982
- Date Received
- Mar 11, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Elevator, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k)