The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22).
| Device ID | K963570 |
| 510k Number | K963570 |
| Device Name: | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) |
| Classification | Manometer, Spinal-fluid |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Product Code | FMJ |
| CFR Regulation Number | 880.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-05 |
| Decision Date | 1996-10-18 |
| Summary: | summary |