The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Irrigation Tray With Piston Syringe.
| Device ID | K942221 | 
| 510k Number | K942221 | 
| Device Name: | IRRIGATION TRAY WITH PISTON SYRINGE | 
| Classification | Syringe, Piston | 
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 | 
| Contact | Parth Basumallik | 
| Correspondent | Parth Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 | 
| Product Code | FMF | 
| CFR Regulation Number | 880.5860 [🔎] | 
| Decision | Substantially Equivalent - Kit (SESK) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1994-05-06 | 
| Decision Date | 1994-08-05 |