510(k) K830399
K830399 is an FDA 510(k) premarket notification submitted by Khi, Inc. for the device "COUPLING/VALVE". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Khi, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1983
- Date Received
- February 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Reservoir
- Device Class
- Class I
- Regulation Number
- 868.5320
- Review Panel
- AN
- Submission Type