The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Blunt Tuohy Epidural Needle.
| Device ID | K954706 |
| 510k Number | K954706 |
| Device Name: | KENDALL BLUNT TUOHY EPIDURAL NEEDLE |
| Classification | Anesthesia Conduction Kit |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-12 |
| Decision Date | 1996-05-30 |
| Summary: | summary |