510(k) K902835
K902835 is an FDA 510(k) premarket notification submitted by Richard James, Inc. for the device "FTS-100 FLUID TRANSFER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 10, 1990. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Richard James, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1990
- Date Received
- June 28, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type