The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Cospan Pediatric Continuous Spinal Anesthesia Tray.
Device ID | K902312 |
510k Number | K902312 |
Device Name: | COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 2203 ALEXANDER ST. Salt Lake City, UT 84119 |
Contact | John J Vozella |
Correspondent | John J Vozella KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 2203 ALEXANDER ST. Salt Lake City, UT 84119 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-23 |
Decision Date | 1990-07-30 |