The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for I.v. Start Kit, Sterile, Disposable.
Device ID | K923361 |
510k Number | K923361 |
Device Name: | I.V. START KIT, STERILE, DISPOSABLE |
Classification | I.v. Start Kit |
Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Contact | Partha Basumallik |
Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Product Code | LRS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-08 |
Decision Date | 1993-06-28 |