The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor Human Spinal Fluid Control.
| Device ID | K950326 |
| 510k Number | K950326 |
| Device Name: | KENLOR HUMAN SPINAL FLUID CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | KENLOR INDUSTRIES, INC. 1560 EAST EDINGER AVE., SUITE A-1 Santa Ana, CA 92705 |
| Contact | Kamales Som |
| Correspondent | Kamales Som KENLOR INDUSTRIES, INC. 1560 EAST EDINGER AVE., SUITE A-1 Santa Ana, CA 92705 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-03-20 |