The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Safetrak Combined Epidural/spinal Kit.
| Device ID | K941493 |
| 510k Number | K941493 |
| Device Name: | KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | CAZ |
| Subsequent Product Code | BSO |
| Subsequent Product Code | BSP |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-06-22 |