510(k) K834071
K834071 is an FDA 510(k) premarket notification submitted by Hyperion, Inc. for the device "LYMPHANGIOGRAPHY SET SPECIAL 30G". The FDA issued a decision of Substantially Equivalent on January 25, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Hyperion, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 1984
- Date Received
- November 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type