The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Continuous Epidural Anesthesia Tray.
Device ID | K945671 |
510k Number | K945671 |
Device Name: | CONTINUOUS EPIDURAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | TRINITY LABORATORIES, INC. 201 KELLY DR. Salisbury, MD 21801 |
Contact | Partha Basumallik |
Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KELLY DR. Salisbury, MD 21801 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-18 |
Decision Date | 1995-02-16 |