The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Incission & Drainage Tray.
Device ID | K921203 |
510k Number | K921203 |
Device Name: | INCISSION & DRAINAGE TRAY |
Classification | Drape, Surgical |
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 | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-12 |
Decision Date | 1992-08-13 |