510(k) K771432
K771432 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "HICALIQ IVH BAG". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Terumo America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1977
- Date Received
- August 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type