510(k) K891759
K891759 is an FDA 510(k) premarket notification submitted by Kinetic Biomedical Services, Inc. for the device "KINETIC MODEL 330". The FDA issued a decision of Substantially Equivalent on April 19, 1989. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Kinetic Biomedical Services, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1989
- Date Received
- March 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Floor Standing
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type