The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Cospan Continuous Spinal Anesthesia Tray.
Device ID | K904101 |
510k Number | K904101 |
Device Name: | COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Contact | John J Vozella |
Correspondent | John J Vozella 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 With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-06 |
Decision Date | 1990-12-04 |