510(k) K132276
K132276 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML". The FDA issued a decision of Substantially Equivalent on November 12, 2013. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Hospira, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2013
- Date Received
- July 22, 2013
- 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