510(k) K963570
K963570 is an FDA 510(k) premarket notification submitted by Smiths Industries Medical Systems, Inc. for the device "SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code FMJ (Manometer, Spinal-Fluid), a Class II device regulated under 21 CFR 880.2500. Smiths Industries Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1996
- Date Received
- September 5, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manometer, Spinal-Fluid
- Device Class
- Class II
- Regulation Number
- 880.2500
- Review Panel
- HO
- Submission Type