The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Safetap Spinal Anesthesia Tray.
Device ID | K953766 |
510k Number | K953766 |
Device Name: | KENDALL SAFETAP SPINAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Contact | Paul W Evans |
Correspondent | Paul W Evans 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 - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-14 |
Decision Date | 1995-11-24 |