The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for General Purpose Instrument Tray, Sterile, Disposab.
| Device ID | K920516 |
| 510k Number | K920516 |
| Device Name: | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | TRINITY LABORATORIES, INC. P.O. BOX 4458 201 KILEY DRIVE Salisbury, MD 21803 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. P.O. BOX 4458 201 KILEY DRIVE Salisbury, MD 21803 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-04 |
| Decision Date | 1992-04-16 |