The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Basic Biopsy Tray. Disposable, Sterile.
| Device ID | K964921 |
| 510k Number | K964921 |
| Device Name: | BASIC BIOPSY TRAY. DISPOSABLE, STERILE |
| Classification | General Surgery Tray |
| 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 | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-01-22 |