510(k) K994323
K994323 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories Co., Ltd. for the device "KAWASUMI LABORATORIES PHILEBOTOMY SET". The FDA issued a decision of Substantially Equivalent on March 8, 2000. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Kawasumi Laboratories Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2000
- Date Received
- December 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type