The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curity(r) Calib Tuohy Type Epidur Needle Fix Wing.
| Device ID | K910791 |
| 510k Number | K910791 |
| Device Name: | CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-25 |
| Decision Date | 1991-05-17 |