The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Curity 20 Gauge Continuous Epidual Anesthe.
Device ID | K930219 |
510k Number | K930219 |
Device Name: | KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE |
Classification | Catheter, Conduction, Anesthetic |
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 | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-15 |
Decision Date | 1993-04-27 |